Home / 510(k) Clearances / K080684

510(k) K080684

WG-SURGICAL SUTURES WITH NEEDLE by Foosin Medical Supplies, Inc. — Product Code GAP

K080684 is an FDA 510(k) premarket notification submitted by Foosin Medical Supplies, Inc. for the device "WG-SURGICAL SUTURES WITH NEEDLE". The FDA issued a decision of Substantially Equivalent on June 9, 2008. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Foosin Medical Supplies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2008
Date Received
March 10, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
Review Panel
SU
Submission Type

Other clearances by Foosin Medical Supplies, Inc.

  • K073614 — WG-SURGICAL SUTURES WITH NEEDLE (April 30, 2008)

Other clearances for product code GAP

  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur (October 18, 2024)
  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)
  • K221767 — Surgical Sutures with or without Needle (July 31, 2023)
  • K180701 — SafePath Suturing System (June 25, 2018)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K162396 — SILK Surgical Suture (November 23, 2016)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)
  • K053638 — MANI NEEDLE & SUTURE PACK (SILK) (May 19, 2006)

FDA data resources