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FDA 510(k)

EndoPilot2

K-Number: K202906 · 2021-04-13

Decision Date2021-04-13
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EndoPilot2 is the device name listed in this FDA 510(k) record. The listed applicant is Schlumbohm GmbH & Co. KG. It received FDA 510(k) clearance on 2021-04-13 under 510(k) number K202906. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoPilot2?

EndoPilot2 is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is Schlumbohm GmbH & Co. KG. The 510(k) number is K202906.

When did EndoPilot2 receive FDA 510(k) clearance?

EndoPilot2 received FDA 510(k) clearance on 2021-04-13, under 510(k) number K202906.

Who is the listed applicant for EndoPilot2?

The FDA 510(k) record lists Schlumbohm GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoPilot2?

The FDA product code for EndoPilot2 is ELC.

Related Devices (Code: ELC)

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.

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.