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510(k) K213610

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps by Katalyst Surgical, LLC — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
November 15, 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 Katalyst Surgical, LLC

  • K192963 — Kogent Torus Ultrasonic Aspirator (June 19, 2020)
  • K163632 — Katalyst Cyclophotocoagulation Probe (June 15, 2017)
  • K141781 — KOGENT SPETZLER LIGHTED SUCTION TUBES (April 9, 2015)
  • K140362 — KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATA (September 15, 2014)
  • K123172 — KOGENT BIPOLAR FORCEPS (December 21, 2012)
  • K121187 — KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES (September 17, 2012)

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