Lithovac Suction/Aspiration Probe
FDA 510(k) K964111 · Electro Medical Systems SA
510(k) numberK964111
Submission
- Device name
- Lithovac Suction/Aspiration Probe
- Applicant
- Electro Medical Systems SA
North Attleboro, MA, US - Received
- October 15, 1996
- Decision date
- December 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KQT – Evacuator, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4370
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KQT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921451 | Evacuator, Gastro-UrologyKQT · Traditional | Northgate Technologies, Inc. | 10/28/1992SE |
| K921088 | Evacuator, Gastro-UrologyKQT · Traditional | Northgate Technologies, Inc. | 10/28/1992SE |
| K910728 | Cleanflow SystemKQT · Traditional | Mitron Technologies, Inc. | 04/01/1991SE |
| K880099 | Van-Tec Bladder EvacuatorKQT · Traditional | Van-Tec, Inc. | 03/02/1988SE |
| K874493 | Bella - Vac IrrigatorKQT · Traditional | Bel-Can Industries | 02/05/1988SE |
| K860266 | Ellik EvacuatorKQT · Traditional | R. J. Ltd., Ind. | 03/05/1986SE |
| K830546 | Dosimetric ReleaseKQT · Traditional | American Hospital Supply Corp. | 05/25/1983SE |
| K811779 | Ross-Emerson Pump, Model 55-RKQT · Traditional | J. H. Emerson Co. | 07/13/1981SE |
| K810739 | Suction Wound Drainage DeviceKQT · Traditional | The Urology Group | 06/26/1981SE |
| K801782 | General Purpose Irrigating/Aspir Syr.KQT · Traditional | The Healthcare Group Laboratories, Inc. | 08/13/1980SE |
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| K002484 | EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis RemovalJDX · Traditional | 10/04/2000SE |
| K991857 | Airflow HandyEFB · Traditional | 10/07/1999SE |
| K992251 | Swiss Lithoclast Multipurpose ProbeFFK · Special | 07/27/1999SE |
| K965203 | Radx SystemEHD · Traditional | 03/17/1997SE |
| K963285 | EMS Swiss Lithoclast LithotripterFFK · Traditional | 02/13/1997SE |
| K953026 | MinipiezonELC · Traditional | 08/28/1995SE |
| K951531 | Swiss Lithoclast LithotripterFFK · Traditional | 08/24/1995SE |
Questions and answers
When was Lithovac Suction/Aspiration Probe cleared by the FDA?
Lithovac Suction/Aspiration Probe (K964111) received a 510(k) decision of Substantially Equivalent on December 16, 1996, 62 days after the submission was received.
What is the product code of K964111?
The FDA product code is KQT – Evacuator, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.4370.