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FDA 510(k)

ENDOFLATOR+; Smart Smoke Evacuation

K-Number: K260209 · 2026-08-19

ApplicantKarl Storz SE & CO. KG
Decision Date2026-08-19
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOFLATOR+; Smart Smoke Evacuation 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 2026-08-19 under 510(k) number K260209. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOFLATOR+; Smart Smoke Evacuation?

ENDOFLATOR+; Smart Smoke Evacuation is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K260209.

When did ENDOFLATOR+; Smart Smoke Evacuation receive FDA 510(k) clearance?

ENDOFLATOR+; Smart Smoke Evacuation received FDA 510(k) clearance on 2026-08-19, under 510(k) number K260209.

Who is the listed applicant for ENDOFLATOR+; Smart Smoke Evacuation?

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 ENDOFLATOR+; Smart Smoke Evacuation?

The FDA product code for ENDOFLATOR+; Smart Smoke Evacuation is HIF.

Other records listing Karl Storz SE & CO. KG as applicant

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Related Devices (Code: HIF)

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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