FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORION RED URETHRAL CATHETER
K Number: K944383
·
Decision Dec 6, 1994
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
81
Applicant Total
21
Review Days
90
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Basic Information
- Device Name
- ORION RED URETHRAL CATHETER
- K Number
- K944383
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Regulatory & Marketing Services, Inc.
- Date Received
- September 7, 1994
- Decision Date
- December 6, 1994
- Product Code
- EZD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EZD | Catheter, Straight | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Regulatory & Marketing Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | Apr 10, 1996 | Substantially Equivalent |
| K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER | Oct 30, 1995 | Substantially Equivalent |
| K941342 | PAIN DOC | Oct 13, 1995 | Substantially Equivalent |
| K941543 | DIAL MEDICAL KIT | Feb 16, 1995 | Unknown |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 | Substantially Equivalent |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Feb 15, 1995 | Substantially Equivalent |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 | Substantially Equivalent |
| K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE | Dec 27, 1994 | Substantially Equivalent |
| K944382 | ORION ALL SILICONE FOLEY CATHETER | Dec 6, 1994 | Substantially Equivalent |
| K944377 | ORION'S URINARY DRAINAGE SET | Dec 6, 1994 | Substantially Equivalent |