POWERED VACUUM ASPIRATOR 1110-G-062— 510(k) K920288

Name: FDA 510(k) clearance K920288
Creator: U.S. Food and Drug Administration
Published: 1992-06-29

Substantially Equivalent

Stirn Industries

FDA 510(k) clearance K920288 for POWERED VACUUM ASPIRATOR 1110-G-062, Substantially Equivalent on 1992-06-29. Applicant: Stirn Industries. Device class: 2.

Clearance details

Applicant: Stirn Industries
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1992-01-22
Decision date: 1992-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, NJ, US

Download summary PDF View on FDA.gov ↗

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K920287 — POWERED VACUUM ASPIRATOR 1110-G-0301992-06-29
K911206 — MAXIMA-101991-11-29

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.