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510(k) K981322

CUTALON NYLON POLYAMIDE SURGICAL SUTURE by Genzyme Surgical Product (Genzyme Biosurgery) — Product Code GAR

K981322 is an FDA 510(k) premarket notification submitted by Genzyme Surgical Product (Genzyme Biosurgery) for the device "CUTALON NYLON POLYAMIDE SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on July 7, 1998. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Genzyme Surgical Product (Genzyme Biosurgery) has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1998
Date Received
April 10, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Device Class
Class II
Regulation Number
878.5020
Review Panel
SU
Submission Type

Other clearances by Genzyme Surgical Product (Genzyme Biosurgery)

  • K001440 — NEXTSTITCH CARDIOVASCULAR VALVE SUTURE (November 13, 2000)
  • K001434 — 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGIC (June 12, 2000)
  • K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (September 3, 1999)
  • K991416 — ENDOSCOPIC CAMERA (July 20, 1999)
  • K991191 — BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE (June 22, 1999)
  • K990062 — SAPHLIFT (March 30, 1999)
  • K982712 — RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 (December 18, 1998)
  • K980016 — MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (August 7, 1998)

Other clearances for product code GAR

  • K261484 — Tissue Approximation System (June 3, 2026)
  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • K212888 — Golnit Nylon Monofilament Suture (March 31, 2022)
  • K212603 — Non Absorbable Surgical Nylon Suture (December 22, 2021)
  • K192420 — Crownjun Nylon Suture (May 29, 2020)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
  • K152795 — RiverLon (Nylon) Suture (October 28, 2015)
  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)

FDA data resources