EVACUATOR, GASTRO-UROLOGY
FDA 510(k) clearance K921451 · decided 1992-10-28
Clearance details
- K-number
- K921451
- Device name
- EVACUATOR, GASTRO-UROLOGY
- Applicant
- Northgate Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-26
- Decision date
- 1992-10-28
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- KQT
- Device class
- 2
- Regulation number
- 876.4370
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Arlington Heights, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LITHOVAC SUCTION/ASPIRATION PROBE (K964111) | Electro Medical Systems SA | 1996-12-16 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus Fluid Aspiration Set; a sterile set of silicone tubing and connectors for use with recall (Z-3179-2011) | Northgate Technologies, Inc. | 2011-09-09 |