FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIDAScope and Introducer Kit, and MIDASystem
K Number: K181982
·
Decision Aug 21, 2018
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
2
Review Days
27
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
- MIDAScope and Introducer Kit, and MIDASystem
- K Number
- K181982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intravu, Inc.
- Date Received
- July 25, 2018
- Decision Date
- August 21, 2018
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRX), ordered by most recent decision date.
Digital ClarusScope System and Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom DS Decompression System
FDA 510(k)
FDA Class 2
·Orthopedic
VantageTM Lumbar Decompression Kit
FDA 510(k)
FDA Class 2
·Orthopedic
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
FDA 510(k)
FDA Class 2
·Orthopedic
PUREVUE FMS
FDA 510(k)
FDA Class 2
·Orthopedic
Articulator Arthroscopic Bur
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Intravu, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243020 | MIDASVu | Dec 2, 2024 | Substantially Equivalent |