AMSCO SURGICAL TABLE
FDA 510(k) clearance K971307 · decided 1997-06-27
Clearance details
- K-number
- K971307
- Device name
- AMSCO SURGICAL TABLE
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 1997-04-08
- Decision date
- 1997-06-27
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- FQO
- Device class
- 1
- Regulation number
- 878.4960
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Maestro System (REF100) (K240598) | Moon Surgical | 2024-06-03 |
| Maestro Platform (K221410) | Moon Surgical | 2022-12-02 |
| STERIS CMAX XLT SURGICAL TABLE (K090136) | STERIS Corporation | 2009-03-20 |
| OPT80 THE TRANSPORTABLE (OPT80) (K972810) | O.P.T. USA, Inc. | 1997-08-26 |
| ALLEN, ULTRA AND SMART SOCKETS (K971988) | Allen Medical Systems, Inc. | 1997-07-11 |
| TENET RADIOLUCENT HAND TABLE (K963506) | Tenet Medical Engineering | 1997-01-09 |
| DRAGER GEMINA WALL-MOUNTED WORKPLACE (K961886) | Alm Surgical Equipment, Inc. | 1996-07-30 |
| DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (K961742) | Alm Surgical Equipment, Inc. | 1996-07-26 |
| TELETOM (K955750) | Berchtold Holding GmbH | 1996-02-08 |
| KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT (K953980) | Kreuzer Corp. | 1995-11-16 |
| LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORY (K951854) | Leonard Medical, Inc. | 1995-06-21 |
| SKYTRON SKYBOOM SERIES (K950192) | Skytron, Div. the Kmw Group, Inc. | 1995-04-03 |
Recalls involving this device
No recalls on record reference this clearance.