KQT
14 FDA 510(k) clearances · Product code
50 daysmedian time to decision
216 days90th percentile
14clearances measured
FDA profile
- Official device name
- Evacuator, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4370
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2005: 8 · 2006: 9 · 2007: 8 · 2008: 6 · 2009: 20 · 2020: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LITHOVAC SUCTION/ASPIRATION PROBE (K964111) | Electro Medical Systems SA | 1996-12-16 |
| EVACUATOR, GASTRO-UROLOGY (K921451) | Northgate Technologies, Inc. | 1992-10-28 |
| EVACUATOR, GASTRO-UROLOGY (K921088) | Northgate Technologies, Inc. | 1992-10-28 |
| CLEANFLOW SYSTEM (K910728) | Mitron Technologies, Inc. | 1991-04-01 |
| VAN-TEC BLADDER EVACUATOR (K880099) | Van-Tec, Inc. | 1988-03-02 |
| BELLA - VAC IRRIGATOR (K874493) | Bel-Can Industries | 1988-02-05 |
| ELLIK EVACUATOR (K860266) | R. J. Ltd., Ind. | 1986-03-05 |
| DOSIMETRIC RELEASE (K830546) | American Hospital Supply Corp. | 1983-05-25 |
| ROSS-EMERSON PUMP, MODEL 55-R (K811779) | J. H. Emerson Co. | 1981-07-13 |
| SUCTION WOUND DRAINAGE DEVICE (K810739) | The Urology Group | 1981-06-26 |
| CATHETER IRRIGATION SYRINGES, #3100,3110 (K801781) | The Healthcare Group Laboratories, Inc. | 1980-08-13 |
| GENERAL PURPOSE IRRIGATING/ASPIR SYR. (K801782) | The Healthcare Group Laboratories, Inc. | 1980-08-13 |
| ELLIK BLADDER EVACUATOR (K800397) | Sage Products, Inc. | 1980-03-10 |
| ELLIK EVACUATOR (K791306) | Davol, Inc. | 1979-08-03 |
Track KQT automatically
Every clearance here is in the API, with alerts when new ones post.