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FDA 510(k)

KARL STORZ SUPRALOOP

K-Number: K254303 · 2026-09-24

ApplicantKarl Storz SE & CO. KG
Decision Date2026-09-24
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KARL STORZ SUPRALOOP is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K254303. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ SUPRALOOP?

KARL STORZ SUPRALOOP is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K254303.

When did KARL STORZ SUPRALOOP receive FDA 510(k) clearance?

KARL STORZ SUPRALOOP received FDA 510(k) clearance on 2026-09-24, under 510(k) number K254303.

Who is the listed applicant for KARL STORZ SUPRALOOP?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ SUPRALOOP?

The FDA product code for KARL STORZ SUPRALOOP is KNF.

Other records listing Karl Storz SE & CO. KG 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.

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Related Devices (Code: KNF)

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.

K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc.

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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