510(k) K070443

INTRACEPT BI-POLAR RF PROBE, MODEL 04814 by Relievant Medsystems, Inc. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 5, 2007
Date Received: February 15, 2007
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 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)
K083856 — INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, (January 22, 2009)

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)