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510(k) K001184

SILK, NONABSORBABLE, SURGICAL SUTURES, USP by Cp Medical — Product Code GAP

K001184 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "SILK, NONABSORBABLE, SURGICAL SUTURES, USP". The FDA issued a decision of SN on June 23, 2000. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Cp Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
June 23, 2000
Date Received
April 11, 2000
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 Cp Medical

  • K173922 — C-PTFETM Surgical Suture (March 26, 2018)
  • K094028 — CP-FIBER (ORTHOFIBER) (March 18, 2010)
  • K072229 — MONOSWIFT (October 5, 2007)
  • K071550 — PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS (July 18, 2007)
  • K060987 — OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 (November 2, 2006)
  • K041894 — ORTHOFIBER (September 17, 2004)
  • K034062 — CP SLEEVE AND RIVER SLEEVE (January 30, 2004)
  • K024372 — CP MEDICAL BONE WAX (June 19, 2003)
  • K030786 — MONO-SWIFT (May 6, 2003)
  • K030351 — STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE (March 28, 2003)

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)

FDA data resources