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) → KQS — Table, Cystometric, Non-Electric And Accessories

# KQS · Table, Cystometric, Non-Electric And Accessories

_Gastroenterology, Urology · 21 CFR 876.4890 · Class 1_

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

## Overview

- **Product Code:** KQS
- **Device Name:** Table, Cystometric, Non-Electric And Accessories
- **Regulation:** [21 CFR 876.4890](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4890)
- **Device Class:** 1
- **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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K955019](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K955019.md) | UROTRACT I | Dornier Medtech America, Inc. | Dec 6, 1995 | SESE |
| [K872022](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K872022.md) | UROVIEW | Oec-Diasonics, Inc. | Jul 16, 1987 | SESE |
| [K864846](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K864846.md) | RADIOGRAPHIC - LEG SECTION | American Sterilizer Co. | Dec 24, 1986 | SESE |
| [K860040](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K860040.md) | HYDRAJUST III UROLOGICAL TABLE | Mallinckrodt Group, Inc. | Feb 10, 1986 | SESE |
| [K852127](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K852127.md) | AMSCO URO-ENDO MOBILE TABLE | American Sterilizer Co. | Aug 8, 1985 | SESE |
| [K801723](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K801723.md) | UR 150-UR 150T | Siemens Corp. | Aug 13, 1980 | SESE |
| [K791699](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K791699.md) | HYDRADJUST II UROLOGICAL TABLE | Sybron Corp. | Oct 22, 1979 | SESE |
| [K760522](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K760522.md) | 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

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

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