510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913101Substantially Equivalent

Peters Cardioflon(tm) Suture

Promedica Products, Inc., Newport Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913101 is the FDA 510(k) clearance record for PETERS CARDIOFLON(TM) SUTURE, a class II device, cleared for Promedica Products, Inc. on under FDA product code GAS (Suture, Nonabsorbable, Synthetic, Polyester). FDA records list 6 510(k) clearances for Promedica Products, Inc., from to . As of , FDA records show no recalls naming K913101.

Clearance record

Decision date
Received
(397 days to decision)
Product code
GAS Suture, Nonabsorbable, Synthetic, Polyester
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Promedica Products, Inc. 620 Newport Center Dr., Newport Beach CA
510(k) summary
Statement
Third party review
No

Clearances, product code GAS

Trailing 12 months

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

FDA records show no clearances under product code GAS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAS, 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