SURGICAL INSTRUMENT KIT, DISPOSABLE— 510(k) K893814

Name: FDA 510(k) clearance K893814
Creator: U.S. Food and Drug Administration
Published: 1989-08-10

Substantially Equivalent

Bioseal

FDA 510(k) clearance K893814 for SURGICAL INSTRUMENT KIT, DISPOSABLE, Substantially Equivalent on 1989-08-10. Applicant: Bioseal. Device class: 2.

Clearance details

Applicant: Bioseal
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1989-05-23
Decision date: 1989-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.