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FDA PMA

Light source system, diagnostic endoscopic

PMA Number: P050027 · 2026-07-21

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2026-07-21
PMA NumberP050027
Product CodeOAY
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

Light source system, diagnostic endoscopic is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code OAY. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Light source system, diagnostic endoscopic?

Light source system, diagnostic endoscopic is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is KARL STORZ Endoscopy-America, Inc..

When did Light source system, diagnostic endoscopic receive FDA 510(k) clearance?

The clearance date for Light source system, diagnostic endoscopic can be found in the official FDA records.

Who is the listed applicant for Light source system, diagnostic endoscopic?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Light source system, diagnostic endoscopic?

The FDA product code for Light source system, diagnostic endoscopic is OAY.

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.

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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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