KQT · Evacuator, Gastro-Urology
Gastroenterology, Urology · 21 CFR 876.4370 · Class 2
Overview
| Product Code | KQT |
|---|---|
| Device Name | Evacuator, Gastro-Urology |
| Regulation | 21 CFR 876.4370 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.
Classification Rationale
(1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Special Controls
*Classification.* (1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Cleared Devices (14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964111 | LITHOVAC SUCTION/ASPIRATION PROBE | Electro Medical Systems SA | Dec 16, 1996 | SESE |
| K921451 | EVACUATOR, GASTRO-UROLOGY | Northgate Technologies, Inc. | Oct 28, 1992 | SESE |
| K921088 | EVACUATOR, GASTRO-UROLOGY | Northgate Technologies, Inc. | Oct 28, 1992 | SESE |
| K910728 | CLEANFLOW SYSTEM | Mitron Technologies, Inc. | Apr 1, 1991 | SESE |
| K880099 | VAN-TEC BLADDER EVACUATOR | Van-Tec, Inc. | Mar 2, 1988 | SESE |
| K874493 | BELLA - VAC IRRIGATOR | Bel-Can Industries | Feb 5, 1988 | SESE |
| K860266 | ELLIK EVACUATOR | R. J. Ltd., Ind. | Mar 5, 1986 | SESE |
| K830546 | DOSIMETRIC RELEASE | American Hospital Supply Corp. | May 25, 1983 | SESE |
| K811779 | ROSS-EMERSON PUMP, MODEL 55-R | J. H. Emerson Co. | Jul 13, 1981 | SESE |
| K810739 | SUCTION WOUND DRAINAGE DEVICE | The Urology Group | Jun 26, 1981 | SESE |
| K801782 | GENERAL PURPOSE IRRIGATING/ASPIR SYR. | The Healthcare Group Laboratories, Inc. | Aug 13, 1980 | SESE |
| K801781 | CATHETER IRRIGATION SYRINGES, #3100,3110 | The Healthcare Group Laboratories, Inc. | Aug 13, 1980 | SESE |
| K800397 | ELLIK BLADDER EVACUATOR | Sage Products, Inc. | Mar 10, 1980 | SESE |
| K791306 | ELLIK EVACUATOR | Davol, Inc. | Aug 3, 1979 | SESE |
Top Applicants
- The Healthcare Group Laboratories, Inc. — 2 clearances
- Northgate Technologies, Inc. — 2 clearances
- Van-Tec, Inc. — 1 clearance
- The Urology Group — 1 clearance
- Sage Products, Inc. — 1 clearance
