MMZ · Table, Cystometric, Electric
Gastroenterology, Urology · 21 CFR 876.4890 · Class 2
Overview
| Product Code | MMZ |
|---|---|
| Device Name | Table, Cystometric, Electric |
| Regulation | 21 CFR 876.4890 |
| Device Class | Class 2 |
| 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 (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033335 | LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS | Siemens Medical Solutions USA, Inc. | Nov 25, 2003 | SESE |
| K954278 | BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 | Beta Medical Products, Inc. | Oct 2, 1995 | SESE |
| K942445 | SYNERGY II | Synectics Medical, Inc. | Nov 22, 1994 | SESE |
| K942485 | MDT UROLOGY TABLE | Mdt Corp., Inc. | Aug 26, 1994 | SESE |
Top Applicants
- Synectics Medical, Inc. — 1 clearance
- Siemens Medical Solutions USA, Inc. — 1 clearance
- Mdt Corp., Inc. — 1 clearance
- Beta Medical Products, Inc. — 1 clearance
