Theia NPWT Foam Wound Dressing Kit— 510(k) K211277

Name: FDA 510(k) clearance K211277
Creator: U.S. Food and Drug Administration
Published: 2021-12-16

Substantially Equivalent

Clear Choice Therapeutics, Inc.

FDA 510(k) clearance K211277 for Theia NPWT Foam Wound Dressing Kit, Substantially Equivalent on 2021-12-16. Applicant: Clear Choice Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Clear Choice Therapeutics, Inc.
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2021-04-27
Decision date: 2021-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, GA, US

Download summary PDF View on FDA.gov ↗

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K261291 — Nisus NPWT Canister 500-mL (CPC-500)2026-05-21

Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.