MODIFICATION TO EN-BLOC BIOPSY SYSTEM— 510(k) K033427
Substantially EquivalentNeothermia Corp.
FDA 510(k) clearance K033427 for MODIFICATION TO EN-BLOC BIOPSY SYSTEM, Substantially Equivalent on 2003-11-10. Applicant: Neothermia Corp.. Device class: 2.
Clearance details
- Applicant
- Neothermia Corp.
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Natick, MA, US
Recent devices under product code KNW
view allMore clearances from Neothermia Corp.
view all- K041347 — 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 KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.