Home / 510(k) Clearances / K083856

510(k) K083856

INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 by Relievant Medsystems, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2009
Date Received
December 24, 2008
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 Relievant Medsystems, Inc.

  • K222281 — Intracept Intraosseous Nerve Ablation System (October 26, 2022)
  • K213836 — Intracept Intraosseous Nerve Ablation System (March 11, 2022)
  • K190504 — Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous (May 3, 2019)
  • K180369 — Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) (September 14, 2018)
  • K171143 — Relievant Medsystems RF Generator (August 18, 2017)
  • K170827 — INTRACEPT Intraosseous Nerve Ablation System (August 9, 2017)
  • K153272 — INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set (July 9, 2016)
  • K100641 — INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG001 (March 30, 2010)
  • K070443 — INTRACEPT BI-POLAR RF PROBE, MODEL 04814 (October 5, 2007)

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)