21 CFR 884.4900 — Table, Obstetrical, Ac-Powered (And Accessories)
Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4900
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HDD | Table, Obstetrical, Ac-Powered (And Accessories) | 2 | 7 | |
| HHP | Table, Obstetrical, Manual (And Accessories) | 2 | 2 | |
| KNC | Table, Obstetric (And Accessories) | 2 | 26 |
Special Controls
HDD — Table, Obstetrical, Ac-Powered (And Accessories)
*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.
eCFR
HHP — Table, Obstetrical, Manual (And Accessories)
*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.
eCFR
KNC — Table, Obstetric (And Accessories)
*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.
eCFR
