BIRTCHER ENDOSCOPIC CORKSCREW— 510(k) K931771

Substantially Equivalent

Birtcher Medical Systems, Inc.

FDA 510(k) clearance K931771 for BIRTCHER ENDOSCOPIC CORKSCREW, Substantially Equivalent on 1994-04-25. Applicant: Birtcher Medical Systems, Inc..

Clearance details

Applicant: Birtcher Medical Systems, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1993-04-09
Decision date: 1994-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.