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FDA 510(k)

AWBAT-S, AWBAT-D, AWBAT-M

K-Number: K082869 · 2009-02-06

ApplicantAubrey, Inc.
Decision Date2009-02-06
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

AWBAT-S, AWBAT-D, AWBAT-M is the device name listed in this FDA 510(k) record. The listed applicant is Aubrey, Inc.. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K082869. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AWBAT-S, AWBAT-D, AWBAT-M?

AWBAT-S, AWBAT-D, AWBAT-M is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Aubrey, Inc.. The 510(k) number is K082869.

When did AWBAT-S, AWBAT-D, AWBAT-M receive FDA 510(k) clearance?

AWBAT-S, AWBAT-D, AWBAT-M received FDA 510(k) clearance on 2009-02-06, under 510(k) number K082869.

Who is the listed applicant for AWBAT-S, AWBAT-D, AWBAT-M?

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

What is the FDA product code for AWBAT-S, AWBAT-D, AWBAT-M?

The FDA product code for AWBAT-S, AWBAT-D, AWBAT-M is KGN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aubrey, 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.

K091863AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS

Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

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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