Evacuator, Gastro-Urology
This device is a gastro-urology evacuator used to aspirate and remove fluid, blood clots, or tissue fragments from the bladder or other urological or gastrointestinal spaces during endoscopic or surgical procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQT, regulated under 21 CFR 876.4370 within the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- KQT
- Device Class
- FDA class 2
- Regulation Number
- 876.4370
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K964111 | LITHOVAC SUCTION/ASPIRATION PROBE | Dec 16, 1996 | Substantially Equivalent | Electro Medical Systems SA |
| K921451 | EVACUATOR, GASTRO-UROLOGY | Oct 28, 1992 | Substantially Equivalent | Northgate Technologies, Inc. |
| K921088 | EVACUATOR, GASTRO-UROLOGY | Oct 28, 1992 | Substantially Equivalent | Northgate Technologies, Inc. |
| K910728 | CLEANFLOW SYSTEM | Apr 01, 1991 | Substantially Equivalent | Mitron Technologies, Inc. |
| K880099 | VAN-TEC BLADDER EVACUATOR | Mar 02, 1988 | Substantially Equivalent | Van-Tec, Inc. |
| K874493 | BELLA - VAC IRRIGATOR | Feb 05, 1988 | Substantially Equivalent | Bel-Can Industries |
| K860266 | ELLIK EVACUATOR | Mar 05, 1986 | Substantially Equivalent | R. J. Ltd., Ind. |
| K830546 | DOSIMETRIC RELEASE | May 25, 1983 | Substantially Equivalent | American Hospital Supply Corp. |
| K811779 | ROSS-EMERSON PUMP, MODEL 55-R | Jul 13, 1981 | Substantially Equivalent | J. H. Emerson Co. |
| K810739 | SUCTION WOUND DRAINAGE DEVICE | Jun 26, 1981 | Substantially Equivalent | The Urology Group |
| K801782 | GENERAL PURPOSE IRRIGATING/ASPIR SYR. | Aug 13, 1980 | Substantially Equivalent | The Healthcare Group Laboratories, Inc. |
| K801781 | CATHETER IRRIGATION SYRINGES, #3100,3110 | Aug 13, 1980 | Substantially Equivalent | The Healthcare Group Laboratories, Inc. |
| K800397 | ELLIK BLADDER EVACUATOR | Mar 10, 1980 | Substantially Equivalent | Sage Products, Inc. |
| K791306 | ELLIK EVACUATOR | Aug 03, 1979 | Substantially Equivalent | Davol, Inc. |
FEI Numbers
This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.