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FDA 510(k)

Precision S 4K Sinuscope

K-Number: K253602 · 2026-06-04

ApplicantStryker Endoscopy
Decision Date2026-06-04
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Precision S 4K Sinuscope is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253602. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision S 4K Sinuscope?

Precision S 4K Sinuscope is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Stryker Endoscopy. The 510(k) number is K253602.

When did Precision S 4K Sinuscope receive FDA 510(k) clearance?

Precision S 4K Sinuscope received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253602.

Who is the listed applicant for Precision S 4K Sinuscope?

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

What is the FDA product code for Precision S 4K Sinuscope?

The FDA product code for Precision S 4K Sinuscope is GWG.

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.

NCT07631468PROspect Registry :Post Market Clinical Follow-up StudyNOT_YET_RECRUITING

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Related Devices (Code: GWG)

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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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