Table, Operating-Room, Manual
A manual operating room table is a non-powered, hand-adjusted surgical table used to position patients during operative procedures, with adjustments made mechanically. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FSE, regulated under 21 CFR 878.4950, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- FSE
- Device Class
- FDA class 1
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K860503 | THE POREX RETRACTOR TABLE | Mar 13, 1986 | Substantially Equivalent | POREX MEDICAL |
| K843801 | MASON EQUIPMENT ORGANIZER & ASPEN | Oct 25, 1984 | Substantially Equivalent | ASPEN LABORATORIES, INC. |
| K840027 | OPERATING ROOM STAND | Feb 04, 1984 | Substantially Equivalent | HEALTHMATE, INC. |
| K831042 | CHEMONUCLEOLYSIS TABLE EXTENSION | May 16, 1983 | Substantially Equivalent | ORTHOPEDIC SYSTEMS, INC. |
| K830339 | IMSI/METRIPOND HAND OPERATING TABLE | Apr 12, 1983 | Substantially Equivalent | INTL. MANAGEMENT SERVICES, INC. |
| K822427 | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | Sep 14, 1982 | Substantially Equivalent | SURGI-QUIP INC.U |
| K821924 | TABLE, OPERATING, FIELD 6530-00-709-8155 | Jul 13, 1982 | Substantially Equivalent | EMERSON-SACK-WARNER CORP. |
| K801382 | DISPOSABLE SURGICAL HEAD SUPPORT | Jun 26, 1980 | Substantially Equivalent | INNOVATIVE SURGICAL PRODUCTS INC. |
| K782092 | ARMBOARD CVER, DISPOSABLE | Jan 10, 1979 | Substantially Equivalent | ANAGO, INC. |
| K780868 | CHEST ROLLS | Aug 14, 1978 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K780867 | PAD HOLDER KIT | Aug 14, 1978 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K780866 | CHEST ROLLS HOLDER | Aug 14, 1978 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K760308 | I.V. SUPPORT, TECNOL ARMBOARD | Aug 11, 1976 | Substantially Equivalent | TECNOL NEW JERSEY WOUND CARE, INC. |
FEI Numbers
This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.