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510(k) K053638

MANI NEEDLE & SUTURE PACK (SILK) by Mani, Inc. — Product Code GAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2006
Date Received
December 29, 2005
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

Other clearances by Mani, Inc.

  • K053637 — MANI NEEDLE & SUTURE PACK (NYLON) (May 19, 2006)
  • K053636 — MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) (March 14, 2006)
  • K050150 — MANI NEEDLE & SUTURE PACK (December 5, 2005)

Other clearances for product code GAP

  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • 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)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)