FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
hypodermic Pinpoint GT Needle
K Number: K163437
·
Decision Jun 23, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
645
Review Days
198
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Basic Information
- Device Name
- hypodermic Pinpoint GT Needle
- K Number
- K163437
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- December 7, 2016
- Decision Date
- June 23, 2017
- Product Code
- PVZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| PVZ | Non-Stainless Steel Needle | FDA class 2 | General Hospital |
Other Clearances by C.R. Bard, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | May 29, 2026 | Unknown |
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