Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge

FDA 510(k) K093112 · Coloplast Manufacturing Us, LLC

Substantially Equivalent

510(k) numberK093112

Submission

Device name
Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge
Applicant
Coloplast Manufacturing Us, LLC
Minneapolis, MN, US
Received
October 1, 2009
Decision date
February 1, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5010
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge cleared by the FDA?

Digitex Suture Delivery System, Model 52025, Digitex Suture Cartridge (Size O), Model 52026, Digitex Suture Cartridge (K093112) received a 510(k) decision of Substantially Equivalent on February 1, 2010, 123 days after the submission was received.

What is the product code of K093112?

The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.