GENERAL ASPERATOR— 510(k) K895761

Name: FDA 510(k) clearance K895761
Creator: U.S. Food and Drug Administration
Published: 1989-10-18

Substantially Equivalent

Kolster Methods

FDA 510(k) clearance K895761 for GENERAL ASPERATOR, Substantially Equivalent on 1989-10-18. Applicant: Kolster Methods. Device class: 2.

Clearance details

Applicant: Kolster Methods
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1989-09-26
Decision date: 1989-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kolster Methods

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K935820 — KOLSTER METHODS1994-07-19
K895762 — CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC1989-10-18

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.