FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEAR-IT ANTI-FOG, MODEL PS003
K Number: K022826
·
Decision Oct 9, 2002
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
26
Applicant Total
6
Review Days
44
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
- CLEAR-IT ANTI-FOG, MODEL PS003
- K Number
- K022826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Preservation Solutions, Inc.
- Date Received
- August 26, 2002
- Decision Date
- October 9, 2002
- Product Code
- OCT
- 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 |
|---|---|---|---|
| OCT | Anti Fog Solution And Accessories, Endoscopy | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCT), ordered by most recent decision date.
KnoxFog Anti-fogging Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GOLFF Sterile Anti-Fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
E-Brik Visualization Assistant
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Konix Anti-Fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AMD Anti-Fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VitreOx Anti-fog Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Preservation Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151728 | CoStorSol plus G | Sep 18, 2015 | Substantially Equivalent |
| K091245 | COSTORSOL | Jun 17, 2009 | Substantially Equivalent |
| K083453 | COSTORSOL | Jan 21, 2009 | Substantially Equivalent |
| K080432 | MAPERSOL | Aug 8, 2008 | Substantially Equivalent |
| K073693 | COSTORSOL | Jul 3, 2008 | Substantially Equivalent |