Product code FSE
- Device name
- Table, Operating-Room, Manual
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4950
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K860503 | THE POREX RETRACTOR TABLE | Porex Medical | 1986-03-13 |
| K843801 | MASON EQUIPMENT ORGANIZER & ASPEN | Aspen Laboratories, Inc. | 1984-10-25 |
| K840027 | OPERATING ROOM STAND | Healthmate, Inc. | 1984-02-04 |
| K831042 | CHEMONUCLEOLYSIS TABLE EXTENSION | Orthopedic Systems, Inc. | 1983-05-16 |
| K830339 | IMSI/METRIPOND HAND OPERATING TABLE | Intl. Management Services, Inc. | 1983-04-12 |
| K822427 | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | Surgi-Quip Inc.U | 1982-09-14 |
| K821924 | TABLE, OPERATING, FIELD 6530-00-709-8155 | Emerson-Sack-Warner Corp. | 1982-07-13 |
| K801382 | DISPOSABLE SURGICAL HEAD SUPPORT | Innovative Surgical Products, Inc. | 1980-06-26 |
| K782092 | ARMBOARD CVER, DISPOSABLE | Anago, Inc. | 1979-01-10 |
| K780866 | CHEST ROLLS HOLDER | Devon Industries, Inc. | 1978-08-14 |
| K780867 | PAD HOLDER KIT | Devon Industries, Inc. | 1978-08-14 |
| K780868 | CHEST ROLLS | Devon Industries, Inc. | 1978-08-14 |
| K760308 | I.V. SUPPORT, TECNOL ARMBOARD | Tecnol New Jersey Wound Care, Inc. | 1976-08-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810057372100 | SchureMed | SCHUERCH CORPORATION | 2025-10-29 |
| 00194613018436 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 00194613121105 | MSI Precision Specialty Instruments | Med Saver, Inc. | 2025-08-01 |
| 06970283131071 | BETACLASSIC | Maquet (Suzhou) Co. LTD | 2022-12-07 |
| 06970283131088 | BETACLASSIC | Maquet (Suzhou) Co. LTD | 2022-11-29 |
| 04046768039599 | BETACLASSIC mobile operating table | MAQUET GmbH | 2022-09-22 |
| ESOT006091 | NA | S & T AG | 2022-09-15 |
| ESOT002021 | NA | S & T AG | 2022-09-15 |
| 00810057373794 | SchureMed | SCHUERCH CORPORATION | 2021-09-10 |
| 00810057373787 | SchureMed | SCHUERCH CORPORATION | 2021-09-02 |
| 00860006920708 | Morzine Medical | Morzine Medical LLC | 2021-07-21 |
| 00810057371431 | SchureMed | SCHUERCH CORPORATION | 2020-09-08 |
| 00810057371448 | SchureMed | SCHUERCH CORPORATION | 2020-09-08 |
| 00810045921846 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921853 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921716 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921839 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921822 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921808 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921792 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921785 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921778 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921754 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921747 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921730 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045921723 | ISI | INSTRUMENT SPECIALISTS, INC. | 2020-07-30 |
| 00810045920092 | C-Thru | INSTRUMENT SPECIALISTS, INC. | 2020-07-23 |
| 00810045920108 | C-Thru | INSTRUMENT SPECIALISTS, INC. | 2020-07-23 |
| 10381780464419 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780220855 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-22 |