MICRO OSCILLATING SAW— 510(k) K771915

Name: FDA 510(k) clearance K771915
Creator: U.S. Food and Drug Administration
Published: 1977-10-21

Substantially Equivalent

American Sterilizer Co.

FDA 510(k) clearance K771915 for MICRO OSCILLATING SAW, Substantially Equivalent on 1977-10-21. Applicant: American Sterilizer Co.. Device class: 1.

Clearance details

Applicant: American Sterilizer Co.
Product code: Code HTZ
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1977-10-12
Decision date: 1977-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K850423 — CONCEPT SUCTION SLEEVE1985-03-14

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K922485 — CHEMDI-VHP CHEMICAL INDICATOR1993-09-29
K930493 — QUANTUM 3080 SURGICAL TABLE1993-06-22
K905816 — ORTHOVISION TABLE1991-03-06

Adverse events under product code HTZ

product code HTZ

Malfunction: 1,133
Total: 1,133

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.