Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgrx, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
19 daysmedian FDA review time
85 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081129 | ENSEAL POWERTIP,NSEAL-514D,-525D,-535D,-545D,-514RD,-525RD,- | Surgrx, Inc. | 2008-07-28 | 98 | 0 |
| K072493 | ENSEAL TISSUE SEALING DEVICE | Surgrx, Inc. | 2007-09-27 | 22 | 0 |
| K072177 | ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM | Surgrx, Inc. | 2007-09-05 | 30 | 1 |
| K071728 | MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE | Surgrx, Inc. | 2007-07-13 | 18 | 0 |
| K070896 | ENSEAL PTC TISSUE SEALING DEVICE | Surgrx, Inc. | 2007-04-24 | 22 | 1 |
| K070165 | ENSEAL PTC TRIO | Surgrx, Inc. | 2007-01-29 | 11 | 1 |
| K062949 | ENSEAL PTC TISSUE SEATING SEALING DEVICE | Surgrx, Inc. | 2006-10-18 | 19 | 0 |
| K063097 | ENSEAL PTC TISSUE SEALING DEVICE | Surgrx, Inc. | 2006-10-18 | 8 | 0 |
| K061526 | ENSEAL PTC TISSUE SEALING DEVICE | Surgrx, Inc. | 2006-06-15 | 13 | 0 |
| K050671 | ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | Surgrx, Inc. | 2005-04-01 | 17 | 0 |
| K043008 | SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | Surgrx, Inc. | 2004-11-17 | 16 | 0 |
| K031133 | SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING | Surgrx, Inc. | 2003-07-03 | 85 | 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