MULTIPLE MANUAL SURGICAL INSTRUMENTS— 510(k) K832686

Name: FDA 510(k) clearance K832686
Creator: U.S. Food and Drug Administration
Published: 1983-10-14

Substantially Equivalent

Hirata Sangyo Co. USA, Inc.

FDA 510(k) clearance K832686 for MULTIPLE MANUAL SURGICAL INSTRUMENTS, Substantially Equivalent on 1983-10-14. Applicant: Hirata Sangyo Co. USA, Inc.. Device class: 1.

Clearance details

Applicant: Hirata Sangyo Co. USA, Inc.
Product code: Code HTO
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1983-08-02
Decision date: 1983-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K833542 — SURGICAL INSTRUMENT1983-11-28
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Adverse events under product code HTO

product code HTO

Injury: 404
Malfunction: 20,305
Total: 20,709

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.