Product code FZM
- Device name
- Stool, Operating-Room
- 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 |
|---|---|---|---|
| K890309 | MALIS SURGICAL STOOL | Valley Forge Scientific Corp. | 1989-02-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04260647946123 | Doctor stool ak 447 | AKRUS GmbH & Co. KG | 2026-06-22 |
| 04260647946116 | Doctor stool ak 446 | AKRUS GmbH & Co. KG | 2026-06-22 |
| 04260647946109 | Doctor stool ak 445 | AKRUS GmbH & Co. KG | 2026-06-22 |
| 04057027753217 | UFSK-OSYS Assistant's chair | UFSK-International OSYS GmbH | 2026-03-02 |
| 04057027349366 | UFSK-OSYS Assistant's chair | UFSK-International OSYS GmbH | 2026-03-02 |
| 04057027171257 | UFSK-OSYS Assistant's chair | UFSK-International OSYS GmbH | 2026-03-02 |
| M3687408CBWW1 | INTENSA | GF HEALTH PRODUCTS, INC. | 2023-10-27 |
| 10810087352155 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352148 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352131 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| M368GF1840C21 | LUMEX | GF HEALTH PRODUCTS, INC. | 2021-06-08 |
| M368GF184021 | LUMEX | GF HEALTH PRODUCTS, INC. | 2021-06-08 |
| 10810030863240 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863264 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863257 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863233 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863226 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863219 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863202 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863196 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863189 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863172 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863165 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863158 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863141 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030863134 | NA | MID CENTRAL MEDICAL CORP. | 2020-12-15 |
| 10810030860164 | NA | MID CENTRAL MEDICAL CORP. | 2020-09-15 |
| 10810030860188 | NA | MID CENTRAL MEDICAL CORP. | 2020-09-15 |
| 10810030860201 | NA | MID CENTRAL MEDICAL CORP. | 2020-09-01 |
| 10810030860195 | NA | MID CENTRAL MEDICAL CORP. | 2020-09-01 |