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510(k) K010672

MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE by Gramsmed, LLC — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2001
Date Received
March 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
Review Panel
SU
Submission Type

Other clearances by Gramsmed, LLC

  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • 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)
  • K003001 — GRAMS SILK NONABSORBABLE SUTURE (December 15, 2000)

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  • K253620 — TroClose 1200 (December 16, 2025)
  • K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glyc (October 3, 2025)
  • K233265 — Monotime and Optime R (October 11, 2024)
  • K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (July 12, 2024)
  • K221527 — StitchKit (February 14, 2023)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212810 — MONOFIX PGCL, knotless wound closure device (August 5, 2022)
  • K211792 — StitchKit (July 16, 2021)