UNICLIP SURGICAL CLIP APPLIER— 510(k) K926199

Name: FDA 510(k) clearance K926199
Creator: U.S. Food and Drug Administration
Published: 1993-04-20

Substantially Equivalent

Unisurge, Inc.

FDA 510(k) clearance K926199 for UNICLIP SURGICAL CLIP APPLIER, Substantially Equivalent on 1993-04-20. Applicant: Unisurge, Inc.. Device class: 1.

Clearance details

Applicant: Unisurge, Inc.
Product code: Code GDO
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1992-12-09
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

Download summary PDF View on FDA.gov ↗

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K820837 — DISPOSABLE MULTIPLE LIGATING CLIP1982-05-28
K812291 — ETHICON MULTIPLE LIGATING CLIP APPLIER1981-09-11

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K943502 — UNIGRIP1994-10-07
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K930617 — OBGRIP AND UNITIPS(TM)1993-08-11
K925882 — UNITIPS SURGICAL INSTRUMENTS1993-08-10

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.