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510(k) K190168

Aquas Probes by Genicon, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2019
Date Received
January 31, 2019
Clearance Type
Special
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 Genicon, Inc.

  • K181791 — SIMPLYSTRONG, SIMPLYEZEE (August 21, 2018)
  • K180836 — Genistrong (April 18, 2018)
  • K180579 — Ezee Retrieval (March 19, 2018)
  • K171752 — X-SURGE (October 17, 2017)
  • K162059 — EZEE RETRIEVAL (September 29, 2016)
  • K132375 — GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG (June 12, 2014)
  • K100090 — IMPLANTABLE CLIP (February 2, 2010)
  • K061417 — GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 (October 10, 2006)
  • K041967 — GENICON SUCTION IRRIGATION SYSTEM (November 12, 2004)
  • K041968 — GENICON BIPOLAR FORCEPS MODEL # 600-005-005 (November 3, 2004)

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