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510(k) K210569

Disposable Monopolar Laparoscopic Shafts and Reusable Handles by Dannik, LLC — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2021
Date Received
February 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Dannik, LLC

  • K250411 — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (March 12, 2025)
  • K211019 — Disposable Monopolar Laparoscopic Tips and Reusable Handles (October 28, 2021)
  • K201063 — DANNIK Disposable Monopolar Laparoscopic Instrument (June 9, 2020)
  • K200053 — DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retr (April 21, 2020)
  • K193019 — DANNIK Disposable Monopolar Laparoscopic Instrument (March 4, 2020)
  • K192711 — Dannik Titanium Ligation Clip (December 20, 2019)
  • K192643 — Dannik Laparoscopic Suction Irrigation System (November 19, 2019)

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