E Surgical, LLC
Sparks, NV, US
E SURGICAL, LLC appears in FDA device records in Sparks, NV. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for E Surgical, LLC between 2006 and 2024. The busiest year on record is 2006, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233115 | Hawkeye Control Unit with Eyas Endoscope | HRX | Substantially Equivalent | |
| K231126 | Eblator Device | GEI | Substantially Equivalent | |
| K071080 | ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M | GEI | Substantially Equivalent | |
| K061878 | ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC | GEI | Substantially Equivalent | |
| K060255 | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007499195 | 3007499195 | E SURGICAL, LLC | 150 Isidor Ct, Sparks, NV 89441 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain