ELLIK EVACUATOR
FDA 510(k) clearance K791306 · decided 1979-08-03
Clearance details
- K-number
- K791306
- Device name
- ELLIK EVACUATOR
- Applicant
- Davol, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-16
- Decision date
- 1979-08-03
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- KQT
- Device class
- 2
- Regulation number
- 876.4370
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, 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 (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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Arista AH (P050038/S042) | Davol, Inc. | 2024-11-04 |
| Arista AH (P050038/S040) | Davol, Inc. | 2023-08-09 |
| FlexiTip XL-R Applicator (P050038/S041) | Davol, Inc. | 2023-05-24 |
| Arista AH Absorbable Hemostatic Particles device (P050038/S038) | Davol, Inc. | 2021-10-22 |
| Arista AH Absorbable Hemostatic Particles Device (P050038/S039) | Davol, Inc. | 2021-08-20 |
| Arista AH Absorbable Hemostatic Particles (P050038/S037) | Davol, Inc. | 2021-07-06 |
| Arista AH Absorbable Hemostatic (P050038/S036) | Davol, Inc. | 2020-09-25 |
| Arista AH Absorbable Hemostatic Particles (P050038/S035) | Davol, Inc. | 2020-04-29 |