FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CRYOSTAT
K Number: K072414
·
Decision Apr 7, 2008
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
17
Applicant Total
3
Review Days
223
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
- CRYOSTAT
- K Number
- K072414
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lil Drug Store Products, Inc.
- Date Received
- August 28, 2007
- Decision Date
- April 7, 2008
- Product Code
- LKX
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LKX | Device, Thermal, Hemorrhoids | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKX), ordered by most recent decision date.
Instalief
FDA 510(k)
FDA Unclassified
·Unknown
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
FDA 510(k)
FDA Unclassified
·Unknown
HEMOR-RITE CRYOTHERAPHY
FDA 510(k)
FDA Unclassified
·Unknown
ICE BATON
FDA 510(k)
FDA Unclassified
·Unknown
ANU ICE
FDA 510(k)
FDA Unclassified
·Unknown
HEMORRELIEF DEVICE
FDA 510(k)
FDA Unclassified
·Unknown