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FDA 510(k)

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System

K-Number: K250411 · 2025-03-12

ApplicantDannik, LLC
Decision Date2025-03-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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.

NCT07512973Single-channel Fibroid Morcellation System Used in Clinical Research on Laparoscopic MyomectomyNOT_YET_RECRUITING

Other records listing Dannik, LLC 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.

K211019Disposable Monopolar Laparoscopic Tips and Reusable HandlesK210569Disposable Monopolar Laparoscopic Shafts and Reusable HandlesK201063DANNIK Disposable Monopolar Laparoscopic InstrumentK200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)K193019DANNIK Disposable Monopolar Laparoscopic InstrumentK192711Dannik Titanium Ligation Clip

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Related Devices (Code: GCJ)

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.

K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.IncK261249Universal Seal (5-12 mm)Intuitive Surgical, Inc.K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)FloShield, Inc.K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.

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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