STRYKER MODEL 977 BIRTHING BED
FDA 510(k) clearance K870745 · decided 1987-02-27
Clearance details
- K-number
- K870745
- Device name
- STRYKER MODEL 977 BIRTHING BED
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-25
- Decision date
- 1987-02-27
- Days to decision
- 2 days
- Clearance type
- Traditional
- Product code
- KNC
- Device class
- 2
- Regulation number
- 884.4900
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Kalamazoo, MI, 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 |
|---|---|---|
| L720 EXAMINATION CHAIR (K001261) | Luneau Gynecologie SA | 2000-06-08 |
| NON-LINTING DELIVERY BLANKET (K932035) | Amsco Sterile Recoveries, Inc. | 1994-05-26 |
| MEDICAL DISPOSABLE BEDDING (K924420) | Hill-Rom, Inc. | 1993-12-10 |
| BD6000 THE OPTIMA & BD5000 BIRTHING BED (K914544) | Lic Care, Inc. | 1993-11-24 |
| AFFINITY BED MODEL 3600 SERIES (K915779) | Hill-Rom, Inc. | 1993-02-24 |
| GARDOSI BIRTHING CUSHION (K903973) | Graphic Controls Corp. | 1990-09-27 |
| OBSTETRICAL SAFETY SYSTEM (K884868) | Buckman Co., Inc. | 1989-03-01 |
| PALMER OBSTETRIC BRACE (K864194) | Ad-Tech Medical Instrument Corp | 1987-01-14 |
| MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 (K862931) | Global Medical Prods, Inc. | 1986-08-07 |
| LABOR-DELIVERY STRETCH/BED (K861030) | Adel Medical , Ltd. | 1986-04-23 |
| MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 (K852174) | Daun International, Inc. | 1985-09-06 |
| CAT. NO. S-5300-E BIRTHING BED (K852171) | Shampaine/Wilson | 1985-08-30 |
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 |