510(k) clearance
25G Huber Needle
- 510(k) number
- K254095
- Applicant
- Martech Medical Products
- Decision date
- Sep 18, 2026
- Date received
- Dec 19, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PTI
- Device type
- Non-Coring (Huber) Needle
- Device class
- Class II
- Regulation
- 21 CFR 880.5570
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Harleysville, PA, US