SILICONE CATHETER REPAIR KITS— 510(k) K926374

Unknown

Akcess Medical Products, Inc.

FDA 510(k) clearance K926374 for SILICONE CATHETER REPAIR KITS, Unknown on 1994-10-07. Applicant: Akcess Medical Products, Inc..

Clearance details

Applicant: Akcess Medical Products, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1992-12-22
Decision date: 1994-10-07
Decision: Unknown
Clearance type: Traditional
Location: New Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.