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FDA 510(k)

1-380 PINWHEEL (WARTENBERG)

K-Number: K851749 · 1985-06-13

ApplicantArtiberia
Decision Date1985-06-13
Product CodeGWY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

1-380 PINWHEEL (WARTENBERG) is the device name listed in this FDA 510(k) record. The listed applicant is Artiberia. It received FDA 510(k) clearance on 1985-06-13 under 510(k) number K851749. The device is classified under product code GWY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1-380 PINWHEEL (WARTENBERG)?

1-380 PINWHEEL (WARTENBERG) is a medical device that received FDA 510(k) clearance on 1985-06-13. The listed applicant is Artiberia. The 510(k) number is K851749.

When did 1-380 PINWHEEL (WARTENBERG) receive FDA 510(k) clearance?

1-380 PINWHEEL (WARTENBERG) received FDA 510(k) clearance on 1985-06-13, under 510(k) number K851749.

Who is the listed applicant for 1-380 PINWHEEL (WARTENBERG)?

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

What is the FDA product code for 1-380 PINWHEEL (WARTENBERG)?

The FDA product code for 1-380 PINWHEEL (WARTENBERG) is GWY.

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 Artiberia 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.

K8517451-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON BK85178627-230 TO 27-234 VARIOUS CAST BREAKERS, WOLFK8517191070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERSK8517272020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAK851718930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTESK8517201155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS

View all 79 devices →

Related Devices (Code: GWY)

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.

K050313BIS SRS (SEMI-RESUABLE SENSOR)Aspect Medical Systems, Inc.K942926NEURO-AIDEBurke Neutech, Inc.K871167SENSITESTERDexin Pty. , Ltd.K780422PINWHEELProjects IN Health

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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