FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
MedicloseTM System
K Number: K213271
·
Decision Aug 31, 2023
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
1
Review Days
700
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MedicloseTM System
- K Number
- K213271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Health Value Creation B.V., Trading AS Corporis Medical
- Date Received
- September 30, 2021
- Decision Date
- August 31, 2023
- Product Code
- OCW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCW), ordered by most recent decision date.
Endomina EZFuse system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SimpleStitch Suturing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MaxTack Motorized Fixation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OverStitch NXT Endoscopic Suturing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
endomina system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Su2ura Approximation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology