FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
K Number: K102059
·
Decision Oct 8, 2010
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
95
Applicant Total
50
Review Days
78
Basic Information
- Device Name
- AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
- K Number
- K102059
- 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 MEDICAL SYSTEMS CORPORATION
- Date Received
- July 22, 2010
- Decision Date
- October 8, 2010
- Product Code
- FET
- 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 |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by OLYMPUS MEDICAL SYSTEMS CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K123317 | EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N | Dec 11, 2012 | Substantially Equivalent |
| K122180 | HIGH FLOW INSUFFLANTION UNIT | Nov 13, 2012 | Substantially Equivalent |
| K112680 | EVIS EXERA III VIDEO SYSTEM | Feb 16, 2012 | Substantially Equivalent |
| K110294 | HIGH FLOW INSUFFLATION UNIT UHI-4 | Nov 18, 2011 | Substantially Equivalent |
| K103312 | UPD-Y0003 | May 12, 2011 | Substantially Equivalent |
| K103478 | SINGLE USE BILIARY DRAINAGE STENT V | Feb 24, 2011 | Substantially Equivalent |
| K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO | Feb 23, 2011 | Substantially Equivalent |
| K102763 | SYSTEMS INTEGRATION | Feb 15, 2011 | Substantially Equivalent |
| K102379 | LTF-Y0009; MAJ-YOO41; XOEV-3D1 | Jan 5, 2011 | Substantially Equivalent |
| K101053 | OLYMPUS CF TYPE Y0023-L, Y0023I | Jul 14, 2010 | Substantially Equivalent |