FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPY Cystoscope/Hysteroscope
K Number: K233635
·
Decision Feb 12, 2024
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
101
Review Days
91
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Basic Information
- Device Name
- SPY Cystoscope/Hysteroscope
- K Number
- K233635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Endoscopy
- Date Received
- November 13, 2023
- Decision Date
- February 12, 2024
- Product Code
- HIH
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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