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FDA 510(k)

DANNIK Disposable Monopolar Laparoscopic Instrument

K-Number: K201063 · 2020-06-09

ApplicantDannik
Decision Date2020-06-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DANNIK Disposable Monopolar Laparoscopic Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Dannik. It received FDA 510(k) clearance on 2020-06-09 under 510(k) number K201063. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANNIK Disposable Monopolar Laparoscopic Instrument?

DANNIK Disposable Monopolar Laparoscopic Instrument is a medical device that received FDA 510(k) clearance on 2020-06-09. The listed applicant is Dannik. The 510(k) number is K201063.

When did DANNIK Disposable Monopolar Laparoscopic Instrument receive FDA 510(k) clearance?

DANNIK Disposable Monopolar Laparoscopic Instrument received FDA 510(k) clearance on 2020-06-09, under 510(k) number K201063.

Who is the listed applicant for DANNIK Disposable Monopolar Laparoscopic Instrument?

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 Disposable Monopolar Laparoscopic Instrument?

The FDA product code for DANNIK Disposable Monopolar Laparoscopic Instrument is GEI.

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 HandlesK200053DANNIK 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: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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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