KQS · Table, Cystometric, Non-Electric And Accessories
Gastroenterology, Urology · 21 CFR 876.4890 · Class 1
Overview
| Product Code | KQS |
|---|---|
| Device Name | Table, Cystometric, Non-Electric And Accessories |
| Regulation | 21 CFR 876.4890 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.
Classification Rationale
(1) Class II (special controls) for the electrically powered urological table and accessories. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* (1) Class II (special controls) for the electrically powered urological table and accessories. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the manually powered table and accessories, and for stirrups for electrically powered table. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K955019 | UROTRACT I | Dornier Medtech America, Inc. | Dec 6, 1995 | SESE |
| K872022 | UROVIEW | Oec-Diasonics, Inc. | Jul 16, 1987 | SESE |
| K864846 | RADIOGRAPHIC - LEG SECTION | American Sterilizer Co. | Dec 24, 1986 | SESE |
| K860040 | HYDRAJUST III UROLOGICAL TABLE | Mallinckrodt Group, Inc. | Feb 10, 1986 | SESE |
| K852127 | AMSCO URO-ENDO MOBILE TABLE | American Sterilizer Co. | Aug 8, 1985 | SESE |
| K801723 | UR 150-UR 150T | Siemens Corp. | Aug 13, 1980 | SESE |
| K791699 | HYDRADJUST II UROLOGICAL TABLE | Sybron Corp. | Oct 22, 1979 | SESE |
| K760522 | TABLE, UROSURGICAL | Mallinckrodt Group, Inc. | Dec 16, 1976 | SESE |
Top Applicants
- Mallinckrodt Group, Inc. — 2 clearances
- American Sterilizer Co. — 2 clearances
- Sybron Corp. — 1 clearance
- Siemens Corp. — 1 clearance
- Oec-Diasonics, Inc. — 1 clearance
