FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Arc Endocuff Glide AEG110 & AEG120
K Number: K191067
·
Decision May 30, 2019
Classifications
1
FEI Numbers
116
Registration Numbers
116
Same Product Code
100
Applicant Total
5
Review Days
38
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Basic Information
- Device Name
- Arc Endocuff Glide AEG110 & AEG120
- K Number
- K191067
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boddingtons Plastics, Ltd.
- Date Received
- April 22, 2019
- Decision Date
- May 30, 2019
- 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 |
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