BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS— 510(k) K032700

Name: FDA 510(k) clearance K032700
Creator: U.S. Food and Drug Administration
Published: 2003-10-09

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K032700 for BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS, Substantially Equivalent on 2003-10-09. Applicant: Blackstone Medical, Inc.. Device class: 2.

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2003-09-02
Decision date: 2003-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Springfield, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.