FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
K Number: K131736
·
Decision Aug 22, 2013
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
116
Review Days
70
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Basic Information
- Device Name
- MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
- K Number
- K131736
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- June 13, 2013
- Decision Date
- August 22, 2013
- 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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