Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4900](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4900) → HHP — Table, Obstetrical, Manual (And Accessories)

# HHP · Table, Obstetrical, Manual (And Accessories)

_Obstetrics/Gynecology · 21 CFR 884.4900 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHP

## Overview

- **Product Code:** HHP
- **Device Name:** Table, Obstetrical, Manual (And Accessories)
- **Regulation:** [21 CFR 884.4900](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4900)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K963505](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHP/K963505.md) | TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM | Tenet Medical Engineering | Feb 14, 1997 | SESE |
| [K822812](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHP/K822812.md) | YSI MODEL 23L LACTATE ANALYZER | Yellow Springs Instrument Co., Inc. | Dec 13, 1982 | SESE |

## Top Applicants

- Tenet Medical Engineering — 1 clearance
- Yellow Springs Instrument Co., Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHP](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HHP)

**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
