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FDA 510(k)

danumed Extension Set for Gastrostomy Button

K-Number: K260110 · 2026-09-10

Decision Date2026-09-10
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

danumed Extension Set for Gastrostomy Button is the device name listed in this FDA 510(k) record. The listed applicant is Danumed Medizintechnik GmbH. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K260110. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the danumed Extension Set for Gastrostomy Button?

danumed Extension Set for Gastrostomy Button is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Danumed Medizintechnik GmbH. The 510(k) number is K260110.

When did danumed Extension Set for Gastrostomy Button receive FDA 510(k) clearance?

danumed Extension Set for Gastrostomy Button received FDA 510(k) clearance on 2026-09-10, under 510(k) number K260110.

Who is the listed applicant for danumed Extension Set for Gastrostomy Button?

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

What is the FDA product code for danumed Extension Set for Gastrostomy Button?

The FDA product code for danumed Extension Set for Gastrostomy Button is PIF.

Related Devices (Code: PIF)

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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