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FDA 510(k)

MEGA ARTHROGRAM KIT

K-Number: K913317 · 1991-10-31

ApplicantMega Medical, Inc.
Decision Date1991-10-31
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEGA ARTHROGRAM KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mega Medical, Inc.. It received FDA 510(k) clearance on 1991-10-31 under 510(k) number K913317. 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 MEGA ARTHROGRAM KIT?

MEGA ARTHROGRAM KIT is a medical device that received FDA 510(k) clearance on 1991-10-31. The listed applicant is Mega Medical, Inc.. The 510(k) number is K913317.

When did MEGA ARTHROGRAM KIT receive FDA 510(k) clearance?

MEGA ARTHROGRAM KIT received FDA 510(k) clearance on 1991-10-31, under 510(k) number K913317.

Who is the listed applicant for MEGA ARTHROGRAM KIT?

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

What is the FDA product code for MEGA ARTHROGRAM KIT?

The FDA product code for MEGA ARTHROGRAM KIT 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 Mega Medical, Inc. 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.

K915863MEGA AMNIOCENTESIS KITK913397MEGA ANGIOGRAM KITK912445MEGA CONTINUOUS EPIDURAL ANESTHESIA KITK913382MEGA PARACENTESIS KITK912322MEGA SPINAL ANESTHESIA KITK912564MEGA PERICARDIOCENTESIS KIT

View all 7 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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