CYLINDRICAL SPONGE
FDA 510(k) clearance K953057 · decided 1995-09-14
Clearance details
- K-number
- K953057
- Device name
- CYLINDRICAL SPONGE
- Applicant
- Medical Perspectives Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-30
- Decision date
- 1995-09-14
- 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
- Norwalk, CT, 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 |
|---|---|---|
| ULTRACELL SUCTION SPONGE (K972634) | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| CPR LAP SPONGES (K960236) | Custom Pack Reliability | 1996-03-28 |
| STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE (K955599) | Stryker Corp. | 1996-02-22 |
| 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 |
| 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
No recalls on record reference this clearance.