Table, Urosurgical
FDA 510(k) K760522 · Mallinckrodt Group, Inc.
510(k) numberK760522
Submission
- Device name
- Table, Urosurgical
- Applicant
- Mallinckrodt Group, Inc.
Mchenry, IL, US - Received
- August 26, 1976
- Decision date
- December 16, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQS – Table, Cystometric, Non-Electric And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4890
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KQS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955019 | Urotract IKQS · Traditional | Dornier Medtech America, Inc. | 12/06/1995SE |
| K872022 | UroviewKQS · Traditional | Oec-Diasonics, Inc. | 07/16/1987SE |
| K864846 | Radiographic - Leg SectionKQS · Traditional | American Sterilizer Co. | 12/24/1986SE |
| K860040 | Hydrajust III Urological TableKQS · Traditional | Mallinckrodt Group, Inc. | 02/10/1986SE |
| K852127 | Amsco Uro-Endo Mobile TableKQS · Traditional | American Sterilizer Co. | 08/08/1985SE |
| K801723 | Ur 150-UR 150TKQS · Traditional | Siemens Corp. | 08/13/1980SE |
| K791699 | Hydradjust II Urological TableKQS · Traditional | Sybron Corp. | 10/22/1979SE |
More from Sybron Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K945053 | LF CT Hig Pressure CathetersFOZ · Traditional | 05/19/1995SE |
| K945140 | Uro-FloLJH · Traditional | 03/08/1995SE |
| K943581 | Hydradjust IV Urological TableIXR · Traditional | 01/04/1995SE |
| K943122 | Surgical DrapesKKX · Traditional | 09/07/1994SE |
| K934664 | HydragownFYA · Traditional | 05/24/1994SE |
| K920742 | Hydrajust IV Urological TableIXR · Traditional | 04/27/1992SE |
| K912944 | CT 8000 Digital Injection SystemDXT · Traditional | 02/04/1992SE |
| K913264 | Hydraview 1000 Digital Image Process/Stor DeviceLLZ · Traditional | 11/01/1991SE |
| K905789 | Franklin 9000 Wall StandKPX · Traditional | 05/20/1991SE |
| K904147 | Hugh Young II Urological X-Ray SystemKPR · Traditional | 12/13/1990SE |
Questions and answers
When was Table, Urosurgical cleared by the FDA?
Table, Urosurgical (K760522) received a 510(k) decision of Substantially Equivalent on December 16, 1976, 112 days after the submission was received.
What is the product code of K760522?
The FDA product code is KQS – Table, Cystometric, Non-Electric And Accessories, a Class I (low risk) device regulated under 21 CFR 876.4890.