E Surgical, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “E Surgical, LLC” (first 2006, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 113 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 | 1 | 104 |
| 2024 | 1 | 132 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name E Surgical, LLC took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| HRX | Arthroscope | 1 | 1 |
Review panels
Most recent E Surgical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233115 | Hawkeye Control Unit with Eyas Endoscope | HRX | 2024-02-06 | 132 |
| K231126 | Eblator Device | GEI | 2023-08-02 | 104 |
| K071080 | ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M | GEI | 2007-08-31 | 136 |
| K061878 | ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC | GEI | 2006-10-24 | 113 |
| K060255 | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE | GEI | 2006-03-31 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named E Surgical, LLC.
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 E Surgical, LLC?
FDA lists 5 510(k) clearances under the applicant name “E Surgical, LLC” (first 2006, latest 2024), 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 E Surgical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name E Surgical, LLC is 113 days.
Which FDA product codes appear under E Surgical, LLC?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); HRX (Arthroscope, 1).
Next steps
- See all 5 E Surgical, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEI, E Surgical, LLC'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.