FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
K Number: K971937
·
Decision Aug 15, 1997
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
42
Applicant Total
143
Review Days
80
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
- CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE
- K Number
- K971937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Medical Corp.
- Date Received
- May 27, 1997
- Decision Date
- August 15, 1997
- Product Code
- OCY
- 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 |
|---|---|---|---|
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCY), ordered by most recent decision date.
EasyPass Guidewire
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Radifocus Glidewire Endoscopic Wire
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NovaGold High Performance Guidewire
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Acrobat Calibrated Tip Wire Guide
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JAGWIRE HIGH PERFORMANCE GUIDWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Terumo Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K111606 | PINNACLE PRECISION ACCESS SYSTEM | Oct 3, 2011 | Substantially Equivalent |
| K111556 | GLIDECROSS SUPPORT CATHETER | Jul 29, 2011 | Substantially Equivalent |
| K110540 | TERUMO SUPPORT CATHETER | May 13, 2011 | Substantially Equivalent |
| K102008 | GLIDESHEATH | Jul 21, 2010 | Substantially Equivalent |
| K091329 | PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH | May 29, 2009 | Substantially Equivalent |
| K082997 | TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER | Apr 15, 2009 | Substantially Equivalent |
| K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | Feb 6, 2009 | Substantially Equivalent |
| K082847 | PINNACLE ROII INTRODUCER SHEATH | Oct 29, 2008 | Substantially Equivalent |
| K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | Sep 26, 2008 | Substantially Equivalent |
| K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | Sep 24, 2008 | Substantially Equivalent |