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510(k) K003590

GRAMS POLYESTER NONABSORBABLE SUTURE by Gramsmed, LLC — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2001
Date Received
November 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
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)
  • 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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  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)