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510(k) K001185

POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP by Cp Medical — Product Code GAW

K001185 is an FDA 510(k) premarket notification submitted by Cp Medical for the device "POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP". The FDA issued a decision of SN on June 23, 2000. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. 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, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
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 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