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510(k) K003001

GRAMS SILK NONABSORBABLE SUTURE by Gramsmed, LLC — Product Code GAP

K003001 is an FDA 510(k) premarket notification submitted by Gramsmed, LLC for the device "GRAMS SILK NONABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on December 15, 2000. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Gramsmed, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2000
Date Received
September 26, 2000
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 Gramsmed, LLC

  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • K010672 — MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE (May 18, 2001)
  • K003017 — GRAMSORB SYNTHETIC ABSORBABLE SUTURE (March 13, 2001)
  • K003590 — GRAMS POLYESTER NONABSORBABLE SUTURE (March 5, 2001)
  • K002999 — GRAMS POLYPROPYLENE NONABSORBABLE SUTURE (December 18, 2000)
  • K003000 — GRAMS NYLON NONABSORBABLE SUTURE (December 18, 2000)

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