FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
K Number: K011886
·
Decision Aug 27, 2001
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
42
Applicant Total
149
Review Days
73
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 EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
- K Number
- K011886
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus America, Inc.
- Date Received
- June 15, 2001
- Decision Date
- August 27, 2001
- Product Code
- ODG
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODG), ordered by most recent decision date.
RIVOS EUS Access Device (M00553900)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
InstaFAN
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ultrasonic Gastrovideoscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EndoSound Vision System; EVS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
FDA 510(k)
FDA Class 2
·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 |