LAPAROSCOPIC ACCESS SHEATH SET— 510(k) K897064

Substantially Equivalent

Cook Ob/Gyn

FDA 510(k) clearance K897064 for LAPAROSCOPIC ACCESS SHEATH SET, Substantially Equivalent on 1990-02-06. Applicant: Cook Ob/Gyn.

Clearance details

Applicant: Cook Ob/Gyn
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1989-12-20
Decision date: 1990-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, 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.