# Neothermia Corp.

- Location (FDA's records): Natick, MA
- FDA decisions: 10 (2001–2005): 10 510(k) clearances
- Names in FDA's records: Neothermia Corp. (7); Neothermia Corporation (3)
- Product codes: GEI (9), KNW (1)
- Predicates its devices cite: 8 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- United States Surgical, A Division of Tyco Healthc: 1 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)

## Firms that cite its devices most
- Chest Innovations, Inc.: 1 (https://510kreport.com/company/chest-innovations)
- Rubicor Medical, Inc.: 1 (https://510kreport.com/company/rubicor-medical)
- Artemis Medical, Inc.: 1 (https://510kreport.com/company/artemis-medical)

## Its most-cited devices
- K003190: EN Bloc Biopsy System (2001), cited by 4
- K050737: Neothermia EN-Bloc Biopsy System (2005), cited by 2
- K020031: EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 (2002), cited by 1
- K021577: Modification to EN-Bloc Biopsy System (2002), cited by 1
- K042170: EN-Bloc Biopsy System Model#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 (2004), cited by 1

## Recent decisions
- K052246: Modification to EN-Bloc Biopsy System (Aug 22, 2005)
- K050737: Neothermia EN-Bloc Biopsy System (Mar 31, 2005)
- K042170: EN-Bloc Biopsy System Model#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 (Sep 7, 2004)
- K041347: Modification to EN-Bloc Biopsy System (Jun 4, 2004)
- K033427: Modification to EN-Bloc Biopsy System (Nov 10, 2003)
- K023413: Modification to Neothermia's EN-Bloc Biopsy System (Nov 8, 2002)
- K022296: Modification to EN-Bloc Biopsy System (Jul 30, 2002)
- K021577: Modification to EN-Bloc Biopsy System (May 29, 2002)

Source page: https://510kreport.com/company/neothermia