FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Rusch Intermittent Urethral Catheters
K Number: K222279
·
Decision Aug 29, 2022
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
6
Applicant Total
39
Review Days
31
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Basic Information
- Device Name
- Rusch Intermittent Urethral Catheters
- K Number
- K222279
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teleflex Medical
- Date Received
- July 29, 2022
- Decision Date
- August 29, 2022
- Product Code
- EZC
- 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 |
|---|---|---|---|
| EZC | Catheter, Coude | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZC), ordered by most recent decision date.
Rusch Intermittent Urethral Catheters
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