CHEMONUCLEOLYSIS TABLE
FDA 510(k) clearance K833509 · decided 1983-11-28
Clearance details
- K-number
- K833509
- Device name
- CHEMONUCLEOLYSIS TABLE
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-11
- Decision date
- 1983-11-28
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- FWY
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ASST-3000 SPINAL SURGERY TABLE (K883457) | Orthopedic Systems, Inc. | 1988-08-26 |
| SKYTRON MODEL 130 SURGICAL TABLE (K873478) | Skytron, Div. the Kmw Group, Inc. | 1987-09-24 |
| CHICK SURGICAL TABLE (K800118) | Warner-Lambert Co. | 1980-02-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |