EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120— 510(k) K042170

Substantially Equivalent

Neothermia Corporation

FDA 510(k) clearance K042170 for EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120, Substantially Equivalent on 2004-09-07. Applicant: Neothermia Corporation.

Clearance details

Applicant: Neothermia Corporation
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2004-08-11
Decision date: 2004-09-07
Decision: Substantially Equivalent
Clearance type: Special
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.