MODIFICATION TO EN-BLOC BIOPSY SYSTEM— 510(k) K041347
Substantially EquivalentNeothermia Corp.
FDA 510(k) clearance K041347 for MODIFICATION TO EN-BLOC BIOPSY SYSTEM, Substantially Equivalent on 2004-06-04. Applicant: Neothermia Corp.. Device class: 2.
Clearance details
- Applicant
- Neothermia Corp.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Natick, MA, US
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- K261070 — LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
More clearances from Neothermia Corp.
view all- K033427 — MODIFICATION TO EN-BLOC BIOPSY SYSTEM
- K023413 — MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
- K022296 — MODIFICATION TO EN-BLOC BIOPSY SYSTEM
- K021577 — MODIFICATION TO EN-BLOC BIOPSY SYSTEM
- K020031 — EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302
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, through . 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.