510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001299Substantially Equivalent for Some Indications

Plain and Chromic Gut Absorbable Surgical Sutures Usp

Cp Medical, Portland OR / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K001299 is the FDA 510(k) clearance record for PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP, a class II device, cleared for Cp Medical on under FDA product code GAL (Suture, Absorbable, Natural). FDA records list 32 510(k) clearances for Cp Medical, from to . As of , FDA records show one recall naming K001299.

Clearance record

Decision date
Received
(60 days to decision)
Product code
GAL Suture, Absorbable, Natural
Regulation
21 CFR 878.4830
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Cp Medical 836 NE 24th Ave., Portland OR
Third party review
No

Clearances, product code GAL

Trailing 12 months

FDA records hold no clearances under product code GAL in the trailing twelve months.

FDA records show no clearances under product code GAL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260