FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
K Number: K151243
·
Decision Aug 20, 2015
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
9
Applicant Total
101
Review Days
101
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Basic Information
- Device Name
- STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
- K Number
- K151243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Endoscopy
- Date Received
- May 11, 2015
- Decision Date
- August 20, 2015
- Product Code
- FCS
- 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 |
|---|---|---|---|
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCS), ordered by most recent decision date.
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FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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FDA Class 2
·Gastroenterology, Urology
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