ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0— 510(k) K031974

Substantially Equivalent

Asap Endoscopic Products GmbH

FDA 510(k) clearance K031974 for ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0, Substantially Equivalent on 2003-09-29. Applicant: Asap Endoscopic Products GmbH.

Clearance details

Applicant: Asap Endoscopic Products GmbH
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2003-06-26
Decision date: 2003-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.