FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Lawson Retrograde Nephrostomy Wire Puncture Set
K Number: K190903
·
Decision Dec 16, 2019
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
55
Applicant Total
175
Review Days
252
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Basic Information
- Device Name
- Lawson Retrograde Nephrostomy Wire Puncture Set
- K Number
- K190903
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- April 8, 2019
- Decision Date
- December 16, 2019
- 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 |
Similar 510(k) Clearances
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In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
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Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
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·Unknown
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
FDA 510(k)
FDA Unclassified
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