Table, Cystometric, Non-Electric And Accessories
This device is a non-electric cystometric table and associated accessories used in urology to perform cystometry, a diagnostic procedure that measures bladder pressure and volume to evaluate bladder function and diagnose voiding disorders. It is classified as FDA Class 1, indicating low risk, subject to general controls only. The product code is KQS, regulated under 21 CFR 876.4890 within the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- KQS
- Device Class
- FDA class 1
- Regulation Number
- 876.4890
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K955019 | UROTRACT I | Dec 06, 1995 | Substantially Equivalent | Dornier Medtech America, Inc. |
| K872022 | UROVIEW | Jul 16, 1987 | Substantially Equivalent | Oec-Diasonics, Inc. |
| K864846 | RADIOGRAPHIC - LEG SECTION | Dec 24, 1986 | Substantially Equivalent | American Sterilizer Co. |
| K860040 | HYDRAJUST III UROLOGICAL TABLE | Feb 10, 1986 | Substantially Equivalent | Mallinckrodt Group, Inc. |
| K852127 | AMSCO URO-ENDO MOBILE TABLE | Aug 08, 1985 | Substantially Equivalent | American Sterilizer Co. |
| K801723 | UR 150-UR 150T | Aug 13, 1980 | Substantially Equivalent | Siemens Corp. |
| K791699 | HYDRADJUST II UROLOGICAL TABLE | Oct 22, 1979 | Substantially Equivalent | Sybron Corp. |
| K760522 | TABLE, UROSURGICAL | Dec 16, 1976 | Substantially Equivalent | Mallinckrodt Group, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.