SOF-FLEX LAPAROSCOPIC BASKET— 510(k) K913299

Substantially Equivalent

Cook Ob/Gyn

FDA 510(k) clearance K913299 for SOF-FLEX LAPAROSCOPIC BASKET, Substantially Equivalent on 1992-02-14. Applicant: Cook Ob/Gyn.

Clearance details

Applicant: Cook Ob/Gyn
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1991-07-25
Decision date: 1992-02-14
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.