FORCEPS, SUTURE, AUTO— 510(k) K772286

Name: FDA 510(k) clearance K772286
Creator: U.S. Food and Drug Administration
Published: 1977-12-20

Substantially Equivalent

Hartmann Group, Inc.

FDA 510(k) clearance K772286 for FORCEPS, SUTURE, AUTO, Substantially Equivalent on 1977-12-20. Applicant: Hartmann Group, Inc.. Device class: 1.

Clearance details

Applicant: Hartmann Group, Inc.
Product code: Code GDO
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1977-12-12
Decision date: 1977-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDO

view all

K926199 — UNICLIP SURGICAL CLIP APPLIER1993-04-20
K890941 — MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP1989-04-07
K890159 — TOWEL CLIPS1989-02-03
K890233 — SUTURE CLIP APPLIER/REMOVER1989-01-27
K820837 — DISPOSABLE MULTIPLE LIGATING CLIP1982-05-28

Adverse events under product code GDO

product code GDO

Death: 5
Malfunction: 2,124
Total: 2,129

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.