Neothermia Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Neothermia Corp.” (first 2001, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 15 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 9 | 9 |
| KNW | Instrument, Biopsy | 1 | 1 |
Review panels
Most recent Neothermia Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052246 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | GEI | 2005-08-22 | 5 |
| K050737 | NEOTHERMIA EN-BLOC BIOPSY SYSTEM | GEI | 2005-03-31 | 10 |
| K042170 | EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 | GEI | 2004-09-07 | 27 |
| K041347 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | GEI | 2004-06-04 | 15 |
| K033427 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | KNW | 2003-11-10 | 13 |
| K023413 | MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM | GEI | 2002-11-08 | 28 |
| K022296 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | GEI | 2002-07-30 | 14 |
| K021577 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | GEI | 2002-05-29 | 15 |
| K020031 | EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 | GEI | 2002-03-27 | 82 |
| K003190 | EN BLOC BIOPSY SYSTEM | GEI | 2001-06-11 | 243 |
Recalls
openFDA lists no recalls under a recalling firm named Neothermia Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Neothermia Corp. (7)
- Neothermia Corporation (3)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neothermia Corp.?
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Neothermia Corp.” (first 2001, latest 2005), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neothermia Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neothermia Corp. is 15 days.
Which FDA product codes appear under Neothermia Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 9); KNW (Instrument, Biopsy, 1).
Next steps
- See all 10 Neothermia Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Neothermia Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.