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FDA 510(k)

PONCY PAK

K-Number: K791843 · 1979-12-19

ApplicantPoncy, Inc.
Decision Date1979-12-19
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PONCY PAK is the device name listed in this FDA 510(k) record. The listed applicant is Poncy, Inc.. It received FDA 510(k) clearance on 1979-12-19 under 510(k) number K791843. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PONCY PAK?

PONCY PAK is a medical device that received FDA 510(k) clearance on 1979-12-19. The listed applicant is Poncy, Inc.. The 510(k) number is K791843.

When did PONCY PAK receive FDA 510(k) clearance?

PONCY PAK received FDA 510(k) clearance on 1979-12-19, under 510(k) number K791843.

Who is the listed applicant for PONCY PAK?

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

What is the FDA product code for PONCY PAK?

The FDA product code for PONCY PAK is KGO.

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 Poncy, 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.

K885122NEEDLE STICK

Related Devices (Code: KGO)

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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