Domain Surgical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Domain Surgical, Inc.” (first 2011, latest 2015), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 128 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 | 1 | 114 |
| 2013 | 0 | — |
| 2014 | 3 | 98 |
| 2015 | 1 | 142 |
| 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 | 4 | 4 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 2 | 2 |
Review panels
Most recent Domain Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142229 | Laparoscopic FMsealer | GEI | 2015-01-02 | 142 |
| K141484 | OPEN FMSEALER | GEI | 2014-07-30 | 55 |
| K140384 | FMWAND HANDPIECE SE | GEI | 2014-05-23 | 98 |
| K130606 | FMWAND FERROMAGNETIC SURGICAL SYSTEM | HGI | 2014-01-03 | 302 |
| K121881 | DOMAIN SURGICAL SYSTEM | HGI | 2012-10-18 | 114 |
| K110439 | DOMAIN SURGICAL SYSTEM | GEI | 2011-07-18 | 153 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-10-24.
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 Domain Surgical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Domain Surgical, Inc.” (first 2011, latest 2015), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Domain Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Domain Surgical, Inc. is 128 days.
Which FDA product codes appear under Domain Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); HGI (Electrocautery, Gynecologic (And Accessories), 2).
Next steps
- See all 6 Domain Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Domain Surgical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.