INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)— 510(k) K901876

Name: FDA 510(k) clearance K901876
Creator: U.S. Food and Drug Administration
Published: 1990-06-28

Substantially Equivalent for Some Indications

Smith & Nephew United, Inc.

FDA 510(k) clearance K901876 for INTRASITE CAVITY WOUND DRESSING (LABEL REVISION), Substantially Equivalent for Some Indications on 1990-06-28. Applicant: Smith & Nephew United, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code KOZ
Device class: Class 1
Regulation: 21 CFR 878.4018
Advisory panel: General, Plastic Surgery
Date received: 1990-04-26
Decision date: 1990-06-28
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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K904604 — REDI-RELEASE ABSORBENT DRESSING1991-01-07
K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING1990-11-21

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K945330 — ALLEVYN ADHESIVE1995-02-09
K943619 — CAVI-CARE CONFORMING FOAM DRESSING1994-08-19
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Adverse events under product code KOZ

product code KOZ

Other: 1
Total: 1

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.