FSE
13 FDA 510(k) clearances · Product code
30 daysmedian time to decision
76 days90th percentile
13clearances measured
FDA profile
- Official device name
- Table, Operating-Room, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1999: 2 · 2000: 1 · 2001: 2 · 2002: 3 · 2005: 2 · 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| THE POREX RETRACTOR TABLE (K860503) | Porex Medical | 1986-03-13 |
| MASON EQUIPMENT ORGANIZER & ASPEN (K843801) | Aspen Laboratories, Inc. | 1984-10-25 |
| OPERATING ROOM STAND (K840027) | Healthmate, Inc. | 1984-02-04 |
| CHEMONUCLEOLYSIS TABLE EXTENSION (K831042) | Orthopedic Systems, Inc. | 1983-05-16 |
| IMSI/METRIPOND HAND OPERATING TABLE (K830339) | Intl. Management Services, Inc. | 1983-04-12 |
| SELF-CONTAINED MOBILE OPHTHAL. OPER. . (K822427) | Surgi-Quip Inc.U | 1982-09-14 |
| TABLE, OPERATING, FIELD 6530-00-709-8155 (K821924) | Emerson-Sack-Warner Corp. | 1982-07-13 |
| DISPOSABLE SURGICAL HEAD SUPPORT (K801382) | Innovative Surgical Products, Inc. | 1980-06-26 |
| ARMBOARD CVER, DISPOSABLE (K782092) | Anago, Inc. | 1979-01-10 |
| CHEST ROLLS HOLDER (K780866) | Devon Industries, Inc. | 1978-08-14 |
| PAD HOLDER KIT (K780867) | Devon Industries, Inc. | 1978-08-14 |
| CHEST ROLLS (K780868) | Devon Industries, Inc. | 1978-08-14 |
| I.V. SUPPORT, TECNOL ARMBOARD (K760308) | Tecnol New Jersey Wound Care, Inc. | 1976-08-11 |
Track FSE automatically
Every clearance here is in the API, with alerts when new ones post.