KNC · Table, Obstetric (And Accessories)
Obstetrics/Gynecology · 21 CFR 884.4900 · Class 2
Overview
| Product Code | KNC |
|---|---|
| Device Name | Table, Obstetric (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.
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001261 | L720 EXAMINATION CHAIR | Luneau Gynecologie SA | Jun 8, 2000 | SESE |
| K932035 | NON-LINTING DELIVERY BLANKET | Amsco Sterile Recoveries, Inc. | May 26, 1994 | SESE |
| K924420 | MEDICAL DISPOSABLE BEDDING | Hill-Rom, Inc. | Dec 10, 1993 | SESE |
| K914544 | BD6000 THE OPTIMA & BD5000 BIRTHING BED | Lic Care, Inc. | Nov 24, 1993 | SESE |
| K915779 | AFFINITY BED MODEL 3600 SERIES | Hill-Rom, Inc. | Feb 24, 1993 | SESE |
| K903973 | GARDOSI BIRTHING CUSHION | Graphic Controls Corp. | Sep 27, 1990 | SESE |
| K884868 | OBSTETRICAL SAFETY SYSTEM | Buckman Co., Inc. | Mar 1, 1989 | SESE |
| K870745 | STRYKER MODEL 977 BIRTHING BED | Stryker Corp. | Feb 27, 1987 | SESE |
| K864194 | PALMER OBSTETRIC BRACE | Ad-Tech Medical Instrument Corp | Jan 14, 1987 | SESE |
| K862931 | MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 | Global Medical Prods, Inc. | Aug 7, 1986 | SESE |
| K861030 | LABOR-DELIVERY STRETCH/BED | Adel Medical , Ltd. | Apr 23, 1986 | SESE |
| K852174 | MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 | Daun International, Inc. | Sep 6, 1985 | SESE |
| K852171 | CAT. NO. S-5300-E BIRTHING BED | Shampaine/Wilson | Aug 30, 1985 | SESE |
| K844183 | PALMER OBSTETIC BRACE | Mic Medical Corp. | Feb 4, 1985 | SESE |
| K842962 | LORRAINE DSL LABOR & DELIVERY BED | Pulley-Kellam Co., Inc. | Sep 25, 1984 | SESE |
| K833321 | LABOR/DELIVERY/RECOVERY BED LDR-600 | Adel Medical , Ltd. | Nov 14, 1983 | SESE |
| K831998 | BIRTHWELL BIRTHING SYSTEM | Qulab Co. | Sep 12, 1983 | SESE |
| K831309 | DELIVERY 4 TABLE | Amsco Co. | Jun 15, 1983 | SESE |
| K830873 | S & W MODEL ASO | S & W Enterprises, Inc. | May 13, 1983 | SESE |
| K820175 | O.N.A.T. | Latex Medical Devices, Inc. | Jan 29, 1982 | SESE |
Top Applicants
- Adel Medical , Ltd. — 3 clearances
- Hill-Rom, Inc. — 2 clearances
- Ad-Tech Medical Instrument Corp — 1 clearance
- Amsco Co. — 1 clearance
- Amsco Sterile Recoveries, Inc. — 1 clearance
