← Product Code [MMZ](/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ) · K942445

# SYNERGY II (K942445)

_Synectics Medical, Inc. · MMZ · Nov 22, 1994 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ/K942445

## Device Facts

- **Applicant:** Synectics Medical, Inc.
- **Product Code:** [MMZ](/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ.md)
- **Decision Date:** Nov 22, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4890
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ/K942445](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/MMZ/K942445)

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