FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JMS CAVEO A.V. Fistula Needle Set
K Number: K251877
·
Decision Aug 15, 2025
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
9
Review Days
58
Basic Information
- Device Name
- JMS CAVEO A.V. Fistula Needle Set
- K Number
- K251877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JMS North America Corporation
- Date Received
- June 18, 2025
- Decision Date
- August 15, 2025
- Product Code
- FIE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
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ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
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JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
FDA 510(k)
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Other Clearances by JMS North America Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K172499 | NEOSHIELD | Jun 1, 2018 | Substantially Equivalent |
| K151017 | JMS Harmony A.V. Fistula Needle Set | May 13, 2015 | Substantially Equivalent |
| K142564 | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) | Dec 23, 2014 | Substantially Equivalent |
| K132321 | JMS SYRINGE | Feb 20, 2014 | Substantially Equivalent |
| K121488 | JMS SAFE WING CATH (SWC) | Mar 5, 2013 | Substantially Equivalent |
| K112178 | JMS APHERESIS NEEDLE SET WINGEATER(R) V2 | Oct 27, 2011 | Substantially Equivalent |
| K111948 | WINGEATER V2 | Oct 24, 2011 | Substantially Equivalent |
| K110157 | SYSLOC MINI V3 | Feb 11, 2011 | Substantially Equivalent |