BREAST STABILIZER— 510(k) K925874

Name: FDA 510(k) clearance K925874
Creator: U.S. Food and Drug Administration
Published: 1993-03-16

Substantially Equivalent

Bip USA, Inc.

FDA 510(k) clearance K925874 for BREAST STABILIZER, Substantially Equivalent on 1993-03-16. Applicant: Bip USA, Inc.. Device class: 1.

Clearance details

Applicant: Bip USA, Inc.
Product code: Code MDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1992-11-19
Decision date: 1993-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niagara Falls, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.