Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4890](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4890) → MMZ — Table, Cystometric, Electric

# MMZ · Table, Cystometric, Electric

_Gastroenterology, Urology · 21 CFR 876.4890 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ

## Overview

- **Product Code:** MMZ
- **Device Name:** Table, Cystometric, Electric
- **Regulation:** [21 CFR 876.4890](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4890)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K033335](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ/K033335.md) | LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS | Siemens Medical Solutions USA, Inc. | Nov 25, 2003 | SESE |
| [K954278](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ/K954278.md) | BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 | Beta Medical Products, Inc. | Oct 2, 1995 | SESE |
| [K942445](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ/K942445.md) | SYNERGY II | Synectics Medical, Inc. | Nov 22, 1994 | SESE |
| [K942485](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ/K942485.md) | MDT UROLOGY TABLE | Mdt Corp., Inc. | Aug 26, 1994 | SESE |

## Top Applicants

- Beta Medical Products, Inc. — 1 clearance
- Mdt Corp., Inc. — 1 clearance
- Siemens Medical Solutions USA, Inc. — 1 clearance
- Synectics Medical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ)

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