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FDA 510(k)

ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

K-Number: K120686 · 2012-04-04

ApplicantCodman & Shurtleff, Inc.
Decision Date2012-04-04
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2012-04-04 under 510(k) number K120686. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM?

ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-04. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K120686.

When did ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM receive FDA 510(k) clearance?

ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM received FDA 510(k) clearance on 2012-04-04, under 510(k) number K120686.

Who is the listed applicant for ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM?

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

What is the FDA product code for ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM?

The FDA product code for ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM is HCG.

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Related Devices (Code: HCG)

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.

K262419MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MFCerenovus, Inc.K261772Target Xtra Detachable CoilStryker NeurovscularK260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.K254221Optima Coil System (OptiOne Coil System)Balt USA, LLCK252694Target Detachable CoilStryker NeurovascularK251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular

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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