KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES— 510(k) K972488

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K972488 for KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES, Substantially Equivalent on 1998-01-22. Applicant: Karl Storz Endoscopy.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1997-07-02
Decision date: 1998-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, 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.