BIOFILM TRANSORBENT ULCER AND WOUND DRESSING— 510(k) K872100

Name: FDA 510(k) clearance K872100
Creator: U.S. Food and Drug Administration
Published: 1987-06-30

Substantially Equivalent for Some Indications

The Bfgoodrich Co.

FDA 510(k) clearance K872100 for BIOFILM TRANSORBENT ULCER AND WOUND DRESSING, Substantially Equivalent for Some Indications on 1987-06-30. Applicant: The Bfgoodrich Co.. Device class: 1.

Clearance details

Applicant: The Bfgoodrich Co.
Product code: Code NAD
Device class: Class 1
Regulation: 21 CFR 878.4020
Advisory panel: General, Plastic Surgery
Date received: 1987-06-01
Decision date: 1987-06-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Brecksville, OH, 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 The Bfgoodrich Co.

view all

K875253 — BFGOODRICH BIOTHANE NON-ADHERENT DRESSING1988-04-13
K872099 — BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS.1987-06-30
K872101 — BIOFILM TRANS. POUCH ULCER & WOUND DRESSING1987-06-30

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.