Cleanflow System
FDA 510(k) K910728 · Mitron Technologies, Inc.
510(k) numberK910728
Submission
- Device name
- Cleanflow System
- Applicant
- Mitron Technologies, Inc.
Dayville, CT, US - Received
- February 20, 1991
- Decision date
- April 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K964111 | Lithovac Suction/Aspiration ProbeKQT · Traditional | Electro Medical Systems SA | 12/16/1996SE |
| K921451 | Evacuator, Gastro-UrologyKQT · Traditional | Northgate Technologies, Inc. | 10/28/1992SE |
| K921088 | Evacuator, Gastro-UrologyKQT · Traditional | Northgate Technologies, Inc. | 10/28/1992SE |
| 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 |
Questions and answers
When was Cleanflow System cleared by the FDA?
Cleanflow System (K910728) received a 510(k) decision of Substantially Equivalent on April 1, 1991, 40 days after the submission was received.
What is the product code of K910728?
The FDA product code is KQT – Evacuator, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.4370.