Home / 510(k) Clearances / K170381

510(k) K170381

Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini by Medtronic Advanced Energy — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2017
Date Received
February 7, 2017
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 Medtronic Advanced Energy

  • K183129 — Medtronic Total Hip Arthroplasty System (July 26, 2019)
  • K181257 — PlasmaBlade X 3.0S, PlasmaBlade X 4.0 (August 2, 2018)
  • K170610 — PlasmaBlade T (April 13, 2017)
  • K170296 — CoreCath 2.7S (March 20, 2017)
  • K152703 — PlasmaBlade TnA Tonsil and Adenoid Dissection Device (July 8, 2016)
  • K150297 — PlasmaBlade UPPP and Suction Coagulator (May 21, 2015)
  • K143175 — AEx Generator; PlasmaBlade T (December 31, 2014)
  • K132974 — AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDUR (December 3, 2013)
  • K123201 — AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER (January 10, 2013)
  • K120909 — EC 2.7 ENDOSCOPIC CUTTER (November 2, 2012)

Other clearances for product code GEI

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K260287 — SP Electrocautery Device (SP20) (February 24, 2026)
  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • K251836 — Dermatrix Duo (February 6, 2026)
  • K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
  • K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
  • K251435 — InbellaIgnite RF System (January 27, 2026)
  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
  • K251988 — Boston iFace (Boston iFace) (January 12, 2026)