General Purpose Irrigating/Aspir Syr.
FDA 510(k) K801782 · The Healthcare Group Laboratories, Inc.
510(k) numberK801782
Submission
- Device name
- General Purpose Irrigating/Aspir Syr.
- Applicant
- The Healthcare Group Laboratories, Inc.
Mchenry, IL, US - Received
- July 28, 1980
- Decision date
- August 13, 1980
- 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 |
| 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 |
More from The Urology Group
| 510(k) | Device | Decision |
|---|---|---|
| K850035 | Empty Solution Transfer ContainerKPE · Traditional | 06/07/1985SE |
| K842170 | Empty Solution Transfer ContainerKPE · Traditional | 10/19/1984SE |
| K842091 | Dispos. Acu-Cut Soft Tissue Biopsy · Traditional | 07/23/1984SE |
| K840742 | Right Atrial CatheterLJS · Traditional | 07/13/1984SE |
| K830299 | Solution Transfer ContainerKPE · Traditional | 02/19/1983SE |
| K822307 | Adhesive Spray #4050-4060KNX · Traditional | 09/24/1982SE |
| K822059 | Show'RbagLGF · Traditional | 07/22/1982SE |
| K821480 | Right Atrial Catheters Parenteral NutritDQY · Traditional | 06/17/1982SE |
| K821230 | Softic 49EBI · Traditional | 05/28/1982SE |
| K821162 | Adhesive RemoverKOX · Traditional | 05/14/1982SE |
Questions and answers
When was General Purpose Irrigating/Aspir Syr. cleared by the FDA?
General Purpose Irrigating/Aspir Syr. (K801782) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 16 days after the submission was received.
What is the product code of K801782?
The FDA product code is KQT – Evacuator, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.4370.