FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pakter Curved Needle Set
K Number: K173155
·
Decision Jun 7, 2018
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
175
Review Days
251
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Basic Information
- Device Name
- Pakter Curved Needle Set
- K Number
- K173155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- September 29, 2017
- Decision Date
- June 7, 2018
- 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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