PATTON LAPAROSCOPIC CATHETER INTRODUCER SET— 510(k) K940265

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K940265 for PATTON LAPAROSCOPIC CATHETER INTRODUCER SET, Substantially Equivalent on 1995-09-28. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-01-21
Decision date: 1995-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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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.