Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
E Surgical, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
136 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | 2024-02-06 | 132 | 0 |
| K231126 | Eblator Device | E Surgical, LLC | 2023-08-02 | 104 | 0 |
| K071080 | ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE | E Surgical, LLC | 2007-08-31 | 136 | 0 |
| K061878 | ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; B | E Surgical, LLC | 2006-10-24 | 113 | 0 |
| K060255 | E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PL | E Surgical, LLC | 2006-03-31 | 58 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda