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FDA 510(k)

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)

K-Number: K200053 · 2020-04-21

ApplicantDannik
Decision Date2020-04-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) is the device name listed in this FDA 510(k) record. The listed applicant is Dannik. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K200053. 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 Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Dannik. The 510(k) number is K200053.

When did DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) receive FDA 510(k) clearance?

DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) received FDA 510(k) clearance on 2020-04-21, under 510(k) number K200053.

Who is the listed applicant for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

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

What is the FDA product code for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)?

The FDA product code for DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) 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.

NCT07762820REtrieval of Transurethrally Resected Intact En-bloc Vesical Tumors Using a Retrieval Device for Bladder TumorsNOT_YET_RECRUITING

Other records listing Dannik 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.

K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemK211019Disposable Monopolar Laparoscopic Tips and Reusable HandlesK210569Disposable Monopolar Laparoscopic Shafts and Reusable HandlesK201063DANNIK Disposable Monopolar Laparoscopic InstrumentK193019DANNIK 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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