DUODERM(R) CGF— 510(k) K881050

Name: FDA 510(k) clearance K881050
Creator: U.S. Food and Drug Administration
Published: 1988-04-01

Substantially Equivalent for Some Indications

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

FDA 510(k) clearance K881050 for DUODERM(R) CGF, Substantially Equivalent for Some Indications on 1988-04-01. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: 1.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code NAD
Device class: Class 1
Regulation: 21 CFR 878.4020
Advisory panel: General, Plastic Surgery
Date received: 1988-03-11
Decision date: 1988-04-01
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NAD

view all

K254246 — LT Antibacterial Foam with Silver Dressing2026-09-10
K102403 — SAM CHEST SEAL WITH VAVLE2011-03-03
K091133 — APLION TOPICAL CARE SYSTEM2009-05-20
K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)2008-06-17
K080524 — CENTURION SORBAVIEW OTC2008-04-23

More clearances from Convatec, A Division of E.R. Squibb & Sons

view all

K013814 — ABSORBENT ANTIMICROBIAL WOUND DRESSING2002-06-21
K990964 — SIGNADRESS DUODERM DRESSING1999-05-18
K984388 — HA ABSORBENT WOUND DRESSING1999-03-03
K980720 — NONWOVEN PAD1998-04-15
K980382 — NON-WOVEN COMPRESS1998-03-09

Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.