25G Huber Needle— 510(k) K254095
Substantially EquivalentMartech Medical Products
FDA 510(k) clearance K254095 for 25G Huber Needle, Substantially Equivalent on 2026-09-18. Applicant: Martech Medical Products. Device class: 2.
Summary
The 25G Huber Needle is from Martech Medical Products, filed under product code PTI (Non-Coring (Huber) Needle). The record doesn't describe the needle beyond its name and code.
Class II, 21 CFR 880.5570. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Martech filed from Harleysville, Pennsylvania. The decision came 273 calendar days after FDA received it (December 19, 2025 to September 18, 2026).
Clearance details
- Applicant
- Martech Medical Products
- Product code
- Product code PTI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5570
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Harleysville, PA, US
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