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FDA 510(k)

MODEL PBD ESU PENCIL

K-Number: K944363 · 1994-12-05

ApplicantCoral Medical, Inc.
Decision Date1994-12-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL PBD ESU PENCIL is the device name listed in this FDA 510(k) record. The listed applicant is Coral Medical, Inc.. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K944363. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL PBD ESU PENCIL?

MODEL PBD ESU PENCIL is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Coral Medical, Inc.. The 510(k) number is K944363.

When did MODEL PBD ESU PENCIL receive FDA 510(k) clearance?

MODEL PBD ESU PENCIL received FDA 510(k) clearance on 1994-12-05, under 510(k) number K944363.

Who is the listed applicant for MODEL PBD ESU PENCIL?

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

What is the FDA product code for MODEL PBD ESU PENCIL?

The FDA product code for MODEL PBD ESU PENCIL is GEI.

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 Coral 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.

K953123QUIK-STITCHK945170QUIK-STITCH

Related Devices (Code: GEI)

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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Official Source

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

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