CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM— 510(k) K935948

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K935948 for CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM, Substantially Equivalent on 1994-03-01. Applicant: Convatec, A Division of E.R. Squibb & Sons.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1993-12-13
Decision date: 1994-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.