FDA 510(k)

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System

Número K: K250411 · 2025-03-12

Data da decisão2025-03-12

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System is the device name listed in this FDA 510(k) record. The listed applicant is Dannik, LLC. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K250411. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System?

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Dannik, LLC. The 510(k) number is K250411.

When did DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System receive FDA 510(k) clearance?

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System received FDA 510(k) clearance on 2025-03-12, under 510(k) number K250411.

Who is the listed applicant for DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System?

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

What is the FDA product code for DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System?

The FDA product code for DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System is GCJ.

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