FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpineSite Endoscope System
K Number: K241990
·
Decision Jul 30, 2025
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
12
Review Days
387
Basic Information
- Device Name
- SpineSite Endoscope System
- K Number
- K241990
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hydrocision, Inc.
- Date Received
- July 8, 2024
- Decision Date
- July 30, 2025
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 Hydrocision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200729 | HydroCision SpineJet System | Apr 16, 2020 | Substantially Equivalent |
| K190804 | HydroCision TenJet Device | Jun 5, 2019 | Substantially Equivalent |
| K041233 | ARTHROJET XT | Jul 28, 2004 | Substantially Equivalent |
| K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 | Sep 16, 2003 | Substantially Equivalent |
| K021813 | HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM | May 9, 2003 | Substantially Equivalent |
| K020688 | HYDROCISION ARTHOJET SYSTEM WITH CAUTERY AND TURBOBURR | Apr 3, 2002 | Substantially Equivalent |
| K011612 | MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM | Jun 22, 2001 | Substantially Equivalent |
| K002764 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR | Nov 24, 2000 | Substantially Equivalent |
| K991383 | HYDROCISION DEBDRIDEMENT SYSTEM | Mar 31, 2000 | Substantially Equivalent |
| K993009 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY | Oct 25, 1999 | Substantially Equivalent |