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FDA 510(k)

FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE

K-Number: K130487 · 2013-06-25

ApplicantPyng Medical Corp.
Decision Date2013-06-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FASTRESPONDER 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 2013-06-25 under 510(k) number K130487. 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 FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE?

FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE is a medical device that received FDA 510(k) clearance on 2013-06-25. The listed applicant is Pyng Medical Corp.. The 510(k) number is K130487.

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

FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE received FDA 510(k) clearance on 2013-06-25, under 510(k) number K130487.

Who is the listed applicant for FASTRESPONDER 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 FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE?

The FDA product code for FASTRESPONDER 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.

K100124FASTX 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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