HDD · Table, Obstetrical, Ac-Powered (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.4900 · Class 2
Overview
| Product Code | HDD |
|---|---|
| Device Name | Table, Obstetrical, Ac-Powered (And Accessories) |
| Regulation | 21 CFR 884.4900 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950889 | ADEL 5000 | Stryker Corp. | Oct 16, 1995 | SESE |
| K914309 | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES | Hill-Rom, Inc. | Apr 20, 1992 | SESE |
| K875123 | ORCEPAD | Alton Dean Medical, Inc. | Jun 21, 1988 | SESE |
| K874610 | ADEL MODEL 2100 BIRTHING BED | Adel Medical , Ltd. | Jan 21, 1988 | SESE |
| K810886 | ADEL MEDICAL BIRTHING BED, #LD-500 | Adel Medical , Ltd. | Apr 23, 1981 | SESE |
| K771942 | TILT 10, CATALOG #S-2600 | Affiliated Hospital Products, Inc. | Oct 27, 1977 | SESE |
| K770438 | CART, PROCEDURES | I E Industries | Jul 1, 1977 | SESE |
Top Applicants
- Adel Medical , Ltd. — 2 clearances
- Stryker Corp. — 1 clearance
- I E Industries — 1 clearance
- Hill-Rom, Inc. — 1 clearance
- Alton Dean Medical, Inc. — 1 clearance
