Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture

• • Terminated Z-2287-2010 FDA Unclassified (pre-2012) ·initiated 1 Feb 2010

  Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.

510(k) Number

K991191 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Nextstitch Cardiovascular Valve Suture

  Class II

  FDA 510(k) K001440 Active Cleared 13 Nov 2000

• Rapid Transfer Blood Bag Model A-1650, Rapid Transfer Blood Bag Model S-250

  Class II

  FDA 510(k) K982712 Active Cleared 18 Dec 1998

• Saphlift

  Class I

  FDA 510(k) K990062 Active Cleared 30 Mar 1999

• Cutalon Nylon Polyamide Surgical Suture

  Class II

  FDA 510(k) K981322 Active Cleared 7 Jul 1998

• Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture

  Class II

  FDA 510(k) K992088 Active Cleared 3 Sep 1999

• 'cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture

  Class II

  FDA 510(k) K001434 Active Cleared 12 Jun 2000

See all devices from Genzyme Surgical Product (Genzyme Biosurgery) →