Surgrx, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Surgrx, Inc.” (first 2003, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 18 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 | 12 | 12 |
Review panels
Most recent Surgrx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081129 | ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, ETRIO-314D,-325D,-335D,-345D, ENSEAL UNIVERSAL | GEI | 2008-07-28 | 98 |
| K072493 | ENSEAL TISSUE SEALING DEVICE | GEI | 2007-09-27 | 22 |
| K072177 | ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM | GEI | 2007-09-05 | 30 |
| K071728 | MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE | GEI | 2007-07-13 | 18 |
| K070896 | ENSEAL PTC TISSUE SEALING DEVICE | GEI | 2007-04-24 | 22 |
| K070165 | ENSEAL PTC TRIO | GEI | 2007-01-29 | 11 |
| K063097 | ENSEAL PTC TISSUE SEALING DEVICE | GEI | 2006-10-18 | 8 |
| K062949 | ENSEAL PTC TISSUE SEATING SEALING DEVICE | GEI | 2006-10-18 | 19 |
| K061526 | ENSEAL PTC TISSUE SEALING DEVICE | GEI | 2006-06-15 | 13 |
| K050671 | ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | GEI | 2005-04-01 | 17 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgrx, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgrx, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Surgrx, Inc.” (first 2003, latest 2008), across 1 product code 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 Surgrx, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgrx, Inc. is 18 days.
Which FDA product codes appear under Surgrx, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 12).
Next steps
- See all 12 Surgrx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Surgrx, Inc.'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.