FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇹 Austria
FiXcision
K Number: K182664
·
Decision Dec 7, 2018
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
4
Review Days
73
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
- FiXcision
- K Number
- K182664
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agency For Medical Innovations GmbH
- Date Received
- September 25, 2018
- Decision Date
- December 7, 2018
- Product Code
- KOA
- 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 |
|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOA), ordered by most recent decision date.
URETHRAL SUTURE GUIDE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LI VASECTOMY
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
VASOVASOSTOMY SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
VESITEC SUTURE PASSER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
DDV LIGATOR
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
NO-SCALPEL VASCETOMY INSTRUMENTS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology