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FDA 510(k)

Altaviz Needle Kit II

K-Number: K231261 · 2023-07-27

ApplicantAltaviz, LLC
Decision Date2023-07-27
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Altaviz Needle Kit II is the device name listed in this FDA 510(k) record. The listed applicant is Altaviz, LLC. It received FDA 510(k) clearance on 2023-07-27 under 510(k) number K231261. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altaviz Needle Kit II?

Altaviz Needle Kit II is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is Altaviz, LLC. The 510(k) number is K231261.

When did Altaviz Needle Kit II receive FDA 510(k) clearance?

Altaviz Needle Kit II received FDA 510(k) clearance on 2023-07-27, under 510(k) number K231261.

Who is the listed applicant for Altaviz Needle Kit II?

The FDA 510(k) record lists Altaviz, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altaviz Needle Kit II?

The FDA product code for Altaviz Needle Kit II is FMI.

Other records listing Altaviz, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243322Altaviz Intravitreal SyringeK222681Altaviz Needle Kit

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech Co., Ltd.

Official Source

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