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510(k) K931917

SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE by Surgimetrics International, Ltd. — Product Code GAW

K931917 is an FDA 510(k) premarket notification submitted by Surgimetrics International, Ltd. for the device "SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE". The FDA issued a decision of Substantially Equivalent on March 3, 1994. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. 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, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
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)
  • K931913 — SUTURE NON-ABSORBABLE SILK (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)

Other clearances for product code GAW

  • K253572 — STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATA (March 27, 2026)
  • K233355 — Cypris eXact Suturing System (January 12, 2024)
  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)

FDA data resources