FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROCISION DEBDRIDEMENT SYSTEM
K Number: K991383
·
Decision Mar 31, 2000
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
12
Review Days
345
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Basic Information
- Device Name
- HYDROCISION DEBDRIDEMENT SYSTEM
- K Number
- K991383
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hydrocision, Inc.
- Date Received
- April 21, 1999
- Decision Date
- March 31, 2000
- Product Code
- FQH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
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Other Clearances by Hydrocision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241990 | SpineSite Endoscope System | Jul 30, 2025 | Substantially Equivalent |
| 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 |
| K993009 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY | Oct 25, 1999 | Substantially Equivalent |