Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgitek Medical Engineering Corp. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
123 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914504 | CYTOLOGY BRUSH | Surgitek Medical Engineering Corp. | 1992-02-18 | 132 | 0 |
| K914495 | E.R.C.P. CATHETER | Surgitek Medical Engineering Corp. | 1992-01-30 | 114 | 0 |
| K914497 | BIOPSY FORCEPS | Surgitek Medical Engineering Corp. | 1992-01-03 | 87 | 0 |
| K914505 | STONE BASKET | Surgitek Medical Engineering Corp. | 1991-12-09 | 61 | 0 |
| K914496 | SCLEROTHERAPY NEEDLE | Surgitek Medical Engineering Corp. | 1991-12-05 | 58 | 0 |
| K914503 | GRASPING FORCEPS | Surgitek Medical Engineering Corp. | 1991-12-05 | 57 | 0 |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | Surgitek Medical Engineering Corp. | 1991-11-19 | 77 | 0 |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | Surgitek Medical Engineering Corp. | 1991-10-04 | 72 | 0 |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | Surgitek Medical Engineering Corp. | 1991-06-25 | 123 | 0 |
| K910768 | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE | Surgitek Medical Engineering Corp. | 1991-03-19 | 25 | 0 |
| K903127 | SURGITEK(R) TURP MONITOR | Surgitek Medical Engineering Corp. | 1990-10-09 | 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