ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER
FDA 510(k) clearance K942753 · decided 1994-11-02
Clearance details
- K-number
- K942753
- Device name
- ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER
- Applicant
- Researched, Novel Medical Devices (Rn/Md)
- Decision
- Substantially Equivalent
- Date received
- 1994-06-10
- Decision date
- 1994-11-02
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- EYZ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sherman Oaks, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| ZIP CONDOM CATHETER (K964219) | Goulter Medical, Inc. | 1997-08-11 |
| UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 (K961906) | Spectrum Medsystems Corp. | 1996-11-19 |
| URINARY GEL DRAINAGE SYSTEM (K952780) | P.A.M., Inc. | 1995-12-12 |
| URINARY DRAINAGE BAG (K951597) | Key Medical Services, Inc. | 1995-08-04 |
| COMFORTCARE SYSTEM (K933126) | Patsy J. Trisler, J.D. | 1994-02-25 |
| NIGHT URINARY DRAINAGE BEDSIDE BAG (K930556) | Ezmt Valve Co., Inc. | 1993-05-14 |
| DYNA-FLO URINARY DRAINAGE BAG (K896695) | Medline Industries, Inc. | 1990-05-02 |
| URO TEX URINALS (K901000) | Sierra Laboratories, Inc. | 1990-03-26 |
| TECNOL SECURE-ALL TUBE HOLDER (K891178) | Tecnol New Jersey Wound Care, Inc. | 1989-05-23 |
| CLOSED SYSTEM URINARY DRAINAGE BAG (K890465) | Cypress Medical Products, Ltd. | 1989-05-23 |
| URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 (K882714) | Lsl Industries, Inc. | 1989-01-31 |
| CATH TRAY W/OUT CATHETER (K780267) | Latex Ind., Inc. | 1978-02-24 |
Recalls involving this device
No recalls on record reference this clearance.