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FDA 510(k)

FASTX STERNAL INTRAOSSEOUS DEVICE

K-Number: K100124 · 2010-08-31

ApplicantPyng Medical Corp.
Decision Date2010-08-31
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FASTX STERNAL INTRAOSSEOUS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pyng Medical Corp.. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K100124. 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 FASTX STERNAL INTRAOSSEOUS DEVICE?

FASTX STERNAL INTRAOSSEOUS DEVICE is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Pyng Medical Corp.. The 510(k) number is K100124.

When did FASTX STERNAL INTRAOSSEOUS DEVICE receive FDA 510(k) clearance?

FASTX STERNAL INTRAOSSEOUS DEVICE received FDA 510(k) clearance on 2010-08-31, under 510(k) number K100124.

Who is the listed applicant for FASTX STERNAL INTRAOSSEOUS DEVICE?

The FDA 510(k) record lists Pyng Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FASTX STERNAL INTRAOSSEOUS DEVICE?

The FDA product code for FASTX STERNAL INTRAOSSEOUS DEVICE is FMI.

Related Clinical Trials

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.

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Other records listing Pyng Medical Corp. 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.

K130487FASTRESPONDER STERNAL INTRAOSSEOUS DEVICEK080865FAST1 INTRAOSSEOUS INFUSION SYSTEMK072487FAST1 INTRAOSSEOUS INFUSION SYSTEMK970380F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.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.

Official Source

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