SYNERGY II
Device Facts
| Record ID | K942445 |
|---|---|
| Device Name | SYNERGY II |
| Applicant | Synectics Medical, Inc. |
| Product Code | MMZ · Gastroenterology, Urology |
| Decision Date | Nov 22, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4890 |
| Device Class | Class 2 |
Regulatory Classification
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.
