FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPUS FB SERIES BIOPSY FORCEPS
K Number: K955065
·
Decision Jan 24, 1996
Classifications
1
FEI Numbers
188
Registration Numbers
188
Same Product Code
38
Applicant Total
149
Review Days
79
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
- OLYMPUS FB SERIES BIOPSY FORCEPS
- K Number
- K955065
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus America, Inc.
- Date Received
- November 6, 1995
- Decision Date
- January 24, 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
INJECTO FLUSH
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SPECTRA SCIENCE BIOPSY FORCEPS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
FORCEPS, BIOPSY, NON-ELECTRIC
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Olympus America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111788 | ENDOEYE HD II | Jan 13, 2012 | Substantially Equivalent |
| K081615 | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | Mar 18, 2009 | Substantially Equivalent |
| K073487 | OLYMPUS IGM REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K073490 | OLYMPUS IGG REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K073489 | OLYMPUS IGA REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | Apr 6, 2007 | Substantially Equivalent |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Mar 23, 2007 | Substantially Equivalent |
| K061499 | OSFERION | Jan 26, 2007 | Substantially Equivalent |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | Nov 29, 2006 | Substantially Equivalent |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Oct 5, 2006 | Substantially Equivalent |