FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
K Number: K182882
·
Decision Nov 14, 2018
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
82
Review Days
30
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
- CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
- K Number
- K182882
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conmed Corporation
- Date Received
- October 15, 2018
- Decision Date
- November 14, 2018
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| 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 Conmed Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K253763 | Y-Knotless Flex Anchors | Jan 29, 2026 | Substantially Equivalent |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Oct 15, 2025 | Substantially Equivalent |
| K251530 | CONMED Argo Knotless® Anchor | Jun 18, 2025 | Substantially Equivalent |
| K250395 | BioBrace ® RC Delivery System | Apr 7, 2025 | Substantially Equivalent |
| K244025 | Argo Knotless GENESYS Anchor | Jan 28, 2025 | Substantially Equivalent |
| K242187 | BioBrace® | Nov 27, 2024 | Substantially Equivalent |
| K240127 | PlumeSafe X5 Smoke Management System | Aug 5, 2024 | Substantially Equivalent |
| K241906 | BioBrace® Reinforced Implant | Jul 29, 2024 | Substantially Equivalent |
| K240090 | Argo Knotless GENESYS Anchor | Mar 5, 2024 | Substantially Equivalent |
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | Oct 23, 2023 | Substantially Equivalent |