Home / 510(k) Clearances / K160623

510(k) K160623

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture by M/s. Meril Endo Surgery Private Limited. — Product Code GAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2016
Date Received
March 4, 2016
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

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  • K232246 — 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; (April 25, 2024)
  • K230981 — Meriglu Topical Skin Adhesive (March 16, 2024)
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  • K172146 — MERISTEEL (February 1, 2018)
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Other clearances for product code GAP

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  • 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)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)
  • K053638 — MANI NEEDLE & SUTURE PACK (SILK) (May 19, 2006)