EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302— 510(k) K020031

Substantially Equivalent

Neothermia Corp.

FDA 510(k) clearance K020031 for EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302, Substantially Equivalent on 2002-03-27. Applicant: Neothermia Corp..

Clearance details

Applicant: Neothermia Corp.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2002-01-04
Decision date: 2002-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.