FLEXON AND STAINLESS STEEL SUTURES— 510(k) K930992

Name: FDA 510(k) clearance K930992
Creator: U.S. Food and Drug Administration
Published: 1993-12-17

Substantially Equivalent

American Cyanamid Co.

FDA 510(k) clearance K930992 for FLEXON AND STAINLESS STEEL SUTURES, Substantially Equivalent on 1993-12-17. Applicant: American Cyanamid Co.. Device class: 2.

Clearance details

Applicant: American Cyanamid Co.
Product code: Code GAQ
Device class: Class 2
Regulation: 21 CFR 878.4495
Advisory panel: General, Plastic Surgery
Date received: 1993-02-25
Decision date: 1993-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAQ

view all

K203855 — CoNextions TR Tendon Repair System2022-04-22
K193209 — Wego-Stainless Steel2020-02-19
K172146 — MERISTEEL2018-02-01
K170767 — Surgical Stainless Steel Suture, Stainless Steel Suture2017-11-01
K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE2014-09-25

More clearances from American Cyanamid Co.

view all

K931056 — DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING1993-07-08
K921696 — CUTTING AND COAGULATION DEVICES AND ACCESSORIES1992-11-18
K922348 — VALTRAC(R) INTRODUCER FORCEP1992-06-09
K900198 — DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.1990-07-05
K896946 — COATED NOVAFIL, POLYBUTESTER, MESH1990-05-07

Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.