FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
K Number: K163292
·
Decision Sep 8, 2017
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
2
Review Days
290
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Basic Information
- Device Name
- Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
- K Number
- K163292
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectra Medical Devices
- Date Received
- November 22, 2016
- Decision Date
- September 8, 2017
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
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Other Clearances by Spectra Medical Devices
| K Number | Device Name | ||
|---|---|---|---|
| K142791 | Spectra Soft Tissue Biopsy Needles | Jan 21, 2015 | Substantially Equivalent |