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) → HDD — Table, Obstetrical, Ac-Powered (And Accessories)

# HDD · Table, Obstetrical, Ac-Powered (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/HDD

## Overview

- **Product Code:** HDD
- **Device Name:** Table, Obstetrical, Ac-Powered (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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K950889](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K950889.md) | ADEL 5000 | Stryker Corp. | Oct 16, 1995 | SESE |
| [K914309](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K914309.md) | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES | Hill-Rom, Inc. | Apr 20, 1992 | SESE |
| [K875123](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K875123.md) | ORCEPAD | Alton Dean Medical, Inc. | Jun 21, 1988 | SESE |
| [K874610](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K874610.md) | ADEL MODEL 2100 BIRTHING BED | Adel Medical , Ltd. | Jan 21, 1988 | SESE |
| [K810886](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K810886.md) | ADEL MEDICAL BIRTHING BED, #LD-500 | Adel Medical , Ltd. | Apr 23, 1981 | SESE |
| [K771942](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K771942.md) | TILT 10, CATALOG #S-2600 | Affiliated Hospital Products, Inc. | Oct 27, 1977 | SESE |
| [K770438](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDD/K770438.md) | CART, PROCEDURES | I E Industries | Jul 1, 1977 | SESE |

## Top Applicants

- Adel Medical , Ltd. — 2 clearances
- Affiliated Hospital Products, Inc. — 1 clearance
- Alton Dean Medical, Inc. — 1 clearance
- Hill-Rom, Inc. — 1 clearance
- I E Industries — 1 clearance

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

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