FSE — Table, Operating-Room, Manual Class I
FDA product code FSE covers "Table, Operating-Room, Manual", a Class I medical device regulated under 21 CFR 878.4950. Submissions are reviewed by the General, Plastic Surgery panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FSE
- Device Class
- Class I
- Regulation Number
- 878.4950
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K860503 | porex medical | THE POREX RETRACTOR TABLE | March 13, 1986 |
| K843801 | aspen laboratories | MASON EQUIPMENT ORGANIZER & ASPEN | October 25, 1984 |
| K840027 | healthmate | OPERATING ROOM STAND | February 4, 1984 |
| K831042 | orthopedic systems | CHEMONUCLEOLYSIS TABLE EXTENSION | May 16, 1983 |
| K830339 | intl. management services | IMSI/METRIPOND HAND OPERATING TABLE | April 12, 1983 |
| K822427 | surgi-quip inc.u | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | September 14, 1982 |
| K821924 | emerson-sack-warner | TABLE, OPERATING, FIELD 6530-00-709-8155 | July 13, 1982 |
| K801382 | innovative surgical products | DISPOSABLE SURGICAL HEAD SUPPORT | June 26, 1980 |
| K782092 | anago | ARMBOARD CVER, DISPOSABLE | January 10, 1979 |
| K780868 | devon industries | CHEST ROLLS | August 14, 1978 |
| K780867 | devon industries | PAD HOLDER KIT | August 14, 1978 |
| K780866 | devon industries | CHEST ROLLS HOLDER | August 14, 1978 |
| K760308 | tecnol new jersey wound care | I.V. SUPPORT, TECNOL ARMBOARD | August 11, 1976 |