360 HEMOCLIP APPLIERS— 510(k) K791157

Name: FDA 510(k) clearance K791157
Creator: U.S. Food and Drug Administration
Published: 1979-06-27

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K791157 for 360 HEMOCLIP APPLIERS, Substantially Equivalent on 1979-06-27. Applicant: Edward Weck, Inc.. Device class: 1.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code GDO
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1979-06-21
Decision date: 1979-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDO

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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

More clearances from Edward Weck, Inc.

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K915378 — WECK TROCAR1992-06-29
K914690 — LM15(TM), CATALOG NUMBER - 5238211992-03-23
K911915 — HEMOCLIP II1992-01-09
K914470 — PNEUMO-SEAL(TM)1991-11-29
K911272 — ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 1147051991-07-02

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.