ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG
FDA 510(k) clearance K944384 · decided 1995-02-15
Clearance details
- K-number
- K944384
- Device name
- ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG
- Applicant
- Regulatory & Marketing Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-07
- Decision date
- 1995-02-15
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- FGM
- Device class
- 1
- Regulation number
- 876.4730
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Palm Harbor, FL, 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 |
|---|---|---|
| CAVERMAP SURGICAL AID (K041732) | Blue Torch Medical Technologies | 2004-09-21 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K031527) | Blue Torch Medical Technologies | 2003-06-05 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K010098) | Uromed Corp. | 2001-02-01 |
| CAVERMAP SURGICAL AID (K993436) | Uromed Corp. | 2000-02-11 |
| ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (K944379) | Regulatory & Marketing Services, Inc. | 1995-02-15 |
| ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (K944378) | Regulatory & Marketing Services, Inc. | 1995-02-15 |
Recalls involving this device
No recalls on record reference this clearance.