Cleared Traditional

Tamper Evident Cap

K231095 · International Medical Industries, Inc. · General Hospital
Sep 2024
Decision
505d
Days
Class 2
Risk

About This 510(k) Submission

K231095 is an FDA 510(k) clearance for the Tamper Evident Cap, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on September 4, 2024, 505 days after receiving the submission on April 18, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K231095 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2023
Decision Date September 04, 2024
Days to Decision 505 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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