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510(k) K903176

ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE by Advance Suture, Inc. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1991
Date Received
July 18, 1990
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 Advance Suture, Inc.

  • K903175 — ADVANCE SUTURE NONABSORBABLE DACRON SUTURE (July 26, 1991)
  • K903174 — ADVANCE SUTURE ABSORBABLE GUT SUTURE (July 10, 1991)
  • K905454 — ADVANCE SUTURE NONABSORBABLE SILK SUTURE (June 28, 1991)
  • K903177 — ADVANCE SUTURE NONABSORBABLE NYLON SUTURE (June 28, 1991)

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  • 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)
  • K173644 — Gazelle Polypropylene Suture and Delivery Device (February 15, 2018)