FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
K Number: K160077
·
Decision Jul 12, 2016
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
55
Applicant Total
1
Review Days
180
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Basic Information
- Device Name
- RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
- K Number
- K160077
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jbw7 Innovations, LLC
- Date Received
- January 14, 2016
- Decision Date
- July 12, 2016
- Product Code
- LJE
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LJE | Catheter, Nephrostomy | FDA unclassified | Unknown |
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