ADEL 5000
FDA 510(k) clearance K950889 · decided 1995-10-16
Clearance details
- K-number
- K950889
- Device name
- ADEL 5000
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-28
- Decision date
- 1995-10-16
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- HDD
- 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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| THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES (K914309) | Hill-Rom, Inc. | 1992-04-20 |
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| ADEL MEDICAL BIRTHING BED, #LD-500 (K810886) | Adel Medical , Ltd. | 1981-04-23 |
| TILT 10, CATALOG #S-2600 (K771942) | Affiliated Hospital Products, Inc. | 1977-10-27 |
| CART, PROCEDURES (K770438) | I E Industries | 1977-07-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker brand Birthing Bed; Model 4701. recall (Z-0793-05) | Stryker Medical | 2005-05-03 |
| Stryker brand Adel maternity bed, model 4700, with night light. recall (Z-0524-04) | Stryker Medical | 2004-02-10 |
| Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light. recall (Z-0525-04) | Stryker Medical | 2004-02-10 |
| Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt recall (Z-0526-04) | Stryker Medical | 2004-02-10 |
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 |