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510(k) K100641

INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) by Relievant Medsystems — Product Code GEI

K100641 is an FDA 510(k) premarket notification submitted by Relievant Medsystems for the device "INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)". The FDA issued a decision of Substantially Equivalent on March 30, 2010. The device falls under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), a Class II device regulated under 21 CFR 878.4400. Relievant Medsystems has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2010
Date Received
March 5, 2010
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

  • 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)
  • K083856 — INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, (January 22, 2009)
  • K070443 — INTRACEPT BI-POLAR RF PROBE, MODEL 04814 (October 5, 2007)

Other clearances for product code GEI

  • K253504 — Volnewmer™ (July 13, 2026)
  • K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 (July 1, 2026)
  • K251492 — Irrigation Tubing Bipolar Cord Set (June 29, 2026)
  • K253484 — LUTRONIC GENIUS (June 29, 2026)
  • K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (June 18, 2026)
  • K253634 — CoolSeal Generator® (CSL-200-90) (June 17, 2026)
  • K261833 — NEUROMARK System (NMK00301) (June 16, 2026)
  • K253165 — LAP-iX2N (June 9, 2026)
  • K253656 — OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (June 5, 2026)
  • K253803 — MILAN System (June 2, 2026)

FDA data resources