Cleared Traditional

JetCan? Pro Safety Huber Needle

K242763 · Pfm Medical, Inc. · General Hospital
May 2025
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K242763 is an FDA 510(k) clearance for the JetCan? Pro Safety Huber Needle, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 2, 2025, 232 days after receiving the submission on September 12, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K242763 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2024
Decision Date May 02, 2025
Days to Decision 232 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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