SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES— 510(k) K910036

Name: FDA 510(k) clearance K910036
Creator: U.S. Food and Drug Administration
Published: 1991-04-04

Substantially Equivalent

Surgical Technologies, Inc.

FDA 510(k) clearance K910036 for SURG TECH,INC. 30 GAUGE STRAIGHT EXTRUSION NEEDLES, Substantially Equivalent on 1991-04-04. Applicant: Surgical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Technologies, Inc.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1991-01-04
Decision date: 1991-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterfield, MO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.