New White Paper Describes babyLance Safety Heelstick 510(k) Application Process
Examines Additional Considerations for Sharps Prevention Features and Submissions for a Modified Medical Device with Existing 510(k) Clearance
Atlanta, GA, April 05, 2013 --(PR.com)-- MediPurpose(tm), a manufacturer and master distributor of medical products, today announced the publication of a new white paper, “Reinventing a Better Safety Heelstick: Obtaining U.S. FDA 510(k) for Sharps Prevention Features.”
The white paper illustrates:
* The meaning and significance of a 510(k) for medical devices with sharps injury prevention features.
* Why MediPurpose applied for a new 510(k) for its babyLance(tm) safety heelstick -- despite having already received clearance for its first generation heelstick device.
* How MediPurpose identified and met the requirements for the 510(k) application.
* The procedures for submitting a 510(k) application.
As described in the white paper, MediPurpose launched the redesigned babyLance safety heelstick in August 2012 as the "babyLance heelstick" -- a Class I device without any safety claims -- while waiting for FDA clearance of its sharps prevention feature indications. The new 510(k) was granted in February 2013, permitting the company to market and label its product as the "babyLance safety heelstick."
"Specifically, the cleared indications for use are that the babyLance is an incision device to obtain a blood sample from the heel of newborn and preemie infants," said MediPurpose founder and CEO Patrick Yi. "The babyLance device has a sharps prevention feature to protect the user from a sharps injury."
To date, babyLance is believed to be the only infant heelstick device marketed in the United States with 510(k) clearance for sharps prevention features.
About babyLance Safety Heelsticks
After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched the all-new heel incision device in August 2012.
babyLance is available in two models, each with a specific blade penetration:
* babyLance BLP (preemie): 0.85 mm depth
* babyLance BLN (newborn): 1.0 mm depth
Specifically designed to meet end-user expectations for the ideal heelstick, the new babyLance provides enhanced stability, comfort and ease of use.
To download the white paper, please visit http://www.medipurpose.com/downloads.
For more information about babyLance safety heelsticks -- including no-cost product sample requests -- please visit www.medipurpose.com/babylance.
About MediPurpose
Founded in 1999, MediPurpose is an innovative medical device company headquartered in Singapore, with offices in the United States and Europe.
Known for its popular babyLance(tm) safety heelstick, SurgiLance(tm) safety lancet and MediPlus(tm) advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and distributors.
MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies that seek entrance into new medical device markets.
For more information about MediPurpose's medical products and solutions for inventors, innovators, manufacturers and distributors, please visit http://www.medipurpose.com.
The white paper illustrates:
* The meaning and significance of a 510(k) for medical devices with sharps injury prevention features.
* Why MediPurpose applied for a new 510(k) for its babyLance(tm) safety heelstick -- despite having already received clearance for its first generation heelstick device.
* How MediPurpose identified and met the requirements for the 510(k) application.
* The procedures for submitting a 510(k) application.
As described in the white paper, MediPurpose launched the redesigned babyLance safety heelstick in August 2012 as the "babyLance heelstick" -- a Class I device without any safety claims -- while waiting for FDA clearance of its sharps prevention feature indications. The new 510(k) was granted in February 2013, permitting the company to market and label its product as the "babyLance safety heelstick."
"Specifically, the cleared indications for use are that the babyLance is an incision device to obtain a blood sample from the heel of newborn and preemie infants," said MediPurpose founder and CEO Patrick Yi. "The babyLance device has a sharps prevention feature to protect the user from a sharps injury."
To date, babyLance is believed to be the only infant heelstick device marketed in the United States with 510(k) clearance for sharps prevention features.
About babyLance Safety Heelsticks
After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched the all-new heel incision device in August 2012.
babyLance is available in two models, each with a specific blade penetration:
* babyLance BLP (preemie): 0.85 mm depth
* babyLance BLN (newborn): 1.0 mm depth
Specifically designed to meet end-user expectations for the ideal heelstick, the new babyLance provides enhanced stability, comfort and ease of use.
To download the white paper, please visit http://www.medipurpose.com/downloads.
For more information about babyLance safety heelsticks -- including no-cost product sample requests -- please visit www.medipurpose.com/babylance.
About MediPurpose
Founded in 1999, MediPurpose is an innovative medical device company headquartered in Singapore, with offices in the United States and Europe.
Known for its popular babyLance(tm) safety heelstick, SurgiLance(tm) safety lancet and MediPlus(tm) advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and distributors.
MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies that seek entrance into new medical device markets.
For more information about MediPurpose's medical products and solutions for inventors, innovators, manufacturers and distributors, please visit http://www.medipurpose.com.
Contact
MediPurpose
Derek Rudnak
888-808-6494
www.medipurpose.com
Derek Rudnak
888-808-6494
www.medipurpose.com
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