TOP STERILE DISPOS. HYPODERMIC NEEDLES— 510(k) K832626

Name: FDA 510(k) clearance K832626
Creator: U.S. Food and Drug Administration
Published: 1983-10-14

Substantially Equivalent

Top Surgical Manufacturers Co.

FDA 510(k) clearance K832626 for TOP STERILE DISPOS. HYPODERMIC NEEDLES, Substantially Equivalent on 1983-10-14. Applicant: Top Surgical Manufacturers Co.. Device class: 1.

Clearance details

Applicant: Top Surgical Manufacturers Co.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1983-08-04
Decision date: 1983-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K844343 — TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE1985-01-08
K843415 — TOP HYPODERMIC SYRINGE LUER LOCK1984-12-07
K843313 — TOP DISPOSABLE SPINAL NEEDLE1984-09-19
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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.