FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IDSS ForceTriad Control Module
K Number: K153205
·
Decision Aug 1, 2016
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
17
Applicant Total
1
Review Days
271
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Basic Information
- Device Name
- IDSS ForceTriad Control Module
- K Number
- K153205
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Black Diamond Video, Inc.
- Date Received
- November 4, 2015
- Decision Date
- August 1, 2016
- Product Code
- ODA
- 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 |
|---|---|---|---|
| ODA | Endoscopic Central Control Unit | FDA class 2 | Gastroenterology, Urology |
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