STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
FDA 510(k) clearance K955599 · decided 1996-02-22
Clearance details
- K-number
- K955599
- Device name
- STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-08
- Decision date
- 1996-02-22
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- GDY
- Device class
- 1
- Regulation number
- 878.4450
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Corp.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ULTRACELL SUCTION SPONGE (K972634) | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| CPR LAP SPONGES (K960236) | Custom Pack Reliability | 1996-03-28 |
| PROTEC X-RAY DETECTABLE GAUZE SPONGE (K955322) | Derivados DE Gasa, S.A. DE C.V. | 1995-12-19 |
| KENSORB (K953830) | Kentron Health Care, Inc. | 1995-10-03 |
| ROSEBUD DISSECTOR (K953060) | Medical Perspectives Corp. | 1995-09-14 |
| CHERRY PIT DISSECTOR (K953087) | Medical Perspectives Corp. | 1995-09-14 |
| CYLINDRICAL SPONGE (K953057) | Medical Perspectives Corp. | 1995-09-14 |
| ROUND STICK SPONGES, FLAT STICK SPONGES (K953058) | Medical Perspectives Corp. | 1995-09-14 |
| TRIANGULAR SPONGES (K953088) | Medical Perspectives Corp. | 1995-09-14 |
| KITTNER DISSECTOR (K953059) | Medical Perspectives Corp. | 1995-09-14 |
| CHERRY DISSECTOR (K953062) | Medical Perspectives Corp. | 1995-09-14 |
| GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) (K951911) | Commercial Resources New Mexico, Ltd. | 1995-06-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Femoral Sponge 10 inches REF 206-715, Rx Sterile, Stryker Instruments Kalamazoo, MI. The f recall (Z-1104-2010) | Stryker Instruments Div. of Stryker Corporation | 2010-03-15 |
| Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF 2 recall (Z-1105-2010) | Stryker Instruments Div. of Stryker Corporation | 2010-03-15 |
| Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile, REF 306-563S10, Stryk recall (Z-1106-2010) | Stryker Instruments Div. of Stryker Corporation | 2010-03-15 |
| ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8, Stryker Instrum recall (Z-1107-2010) | Stryker Instruments Div. of Stryker Corporation | 2010-03-15 |
| ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments, Kal recall (Z-1108-2010) | Stryker Instruments Div. of Stryker Corporation | 2010-03-15 |
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 |