← Product Code [KQS](/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS) · K860040

# HYDRAJUST III UROLOGICAL TABLE (K860040)

_Mallinckrodt Group, Inc. · KQS · Feb 10, 1986 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K860040

## Device Facts

- **Applicant:** Mallinckrodt Group, Inc.
- **Product Code:** [KQS](/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS.md)
- **Decision Date:** Feb 10, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4890
- **Device Class:** Class 1
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K860040](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/KQS/K860040)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com