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510(k) K931913

SUTURE NON-ABSORBABLE SILK by Surgimetrics International, Ltd. — Product Code GAP

K931913 is an FDA 510(k) premarket notification submitted by Surgimetrics International, Ltd. for the device "SUTURE NON-ABSORBABLE SILK". The FDA issued a decision of Substantially Equivalent on March 3, 1994. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Surgimetrics International, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1994
Date Received
April 16, 1993
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 Surgimetrics International, Ltd.

  • K931914 — SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE (October 5, 1994)
  • K931919 — CATGUT SUTURE CHROMIC (March 3, 1994)
  • K931915 — STAINLESS STEEL SUTURE (March 3, 1994)
  • K931916 — SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER (March 3, 1994)
  • K931918 — CATGUT SUTURE PLAIN (March 3, 1994)
  • K931917 — SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE (March 3, 1994)

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)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)

FDA data resources