CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020— 510(k) K932276

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K932276 for CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020, Substantially Equivalent on 1995-02-28. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1993-05-12
Decision date: 1995-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

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.