FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMEDEX FIXATION DEVICE
K Number: K032127
·
Decision Dec 30, 2003
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
63
Applicant Total
4
Review Days
173
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
- HEMEDEX FIXATION DEVICE
- K Number
- K032127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hemedex Incorporated
- Date Received
- July 10, 2003
- Decision Date
- December 30, 2003
- Product Code
- KNY
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNY), ordered by most recent decision date.
Bi-Flex Evo
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Vesair Cystoscopic Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BI-FLEX URETERAL ACCESS SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WIJAY EZ-VOID EXTERNAL CATHETER VALVE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUARDIAN URETHRAL SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUARDIAN URETHRAL SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology