FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INJECTO FLUSH
K Number: K964120
·
Decision Dec 30, 1996
Classifications
1
FEI Numbers
188
Registration Numbers
188
Same Product Code
38
Applicant Total
1
Review Days
76
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
- INJECTO FLUSH
- K Number
- K964120
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Robert J. Jynch, Jr.
- Date Received
- October 15, 1996
- Decision Date
- December 30, 1996
- Product Code
- FCL
- 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 |
|---|---|---|---|
| FCL | Forceps, Biopsy, Non-Electric | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCL), ordered by most recent decision date.
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
AUXILIARY INSTRUMENTS FOR URS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SPECTRA SCIENCE BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
OLYMPUS FB SERIES BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
FORCEPS, BIOPSY, NON-ELECTRIC
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology