FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ReTrace Ureteral Access Sheath
K Number: K181811
·
Decision Sep 7, 2018
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
71
Review Days
63
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Basic Information
- Device Name
- ReTrace Ureteral Access Sheath
- K Number
- K181811
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coloplast A/S
- Date Received
- July 6, 2018
- Decision Date
- September 7, 2018
- Product Code
- FED
- 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 |
|---|---|---|---|
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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| K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM | Jul 24, 2014 | Substantially Equivalent |
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