DUODERM TRANSPARENT HYDROCOLLOID DRESSING— 510(k) K925992

Name: FDA 510(k) clearance K925992
Creator: U.S. Food and Drug Administration
Published: 1993-10-15

Substantially Equivalent

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

FDA 510(k) clearance K925992 for DUODERM TRANSPARENT HYDROCOLLOID DRESSING, Substantially Equivalent on 1993-10-15. 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 KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1992-11-25
Decision date: 1993-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER1996-10-11
K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29

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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 KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.