FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Möller Medical Biopsy Needles and Systems
K Number: K162588
·
Decision Jun 19, 2017
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
3
Review Days
276
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Basic Information
- Device Name
- Möller Medical Biopsy Needles and Systems
- K Number
- K162588
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Moller Medical GmbH
- Date Received
- September 16, 2016
- Decision Date
- June 19, 2017
- Product Code
- KNW
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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