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510(k) K020354

BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) by Baylis Medical Co., Inc. — Product Code GXD

K020354 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2002
Date Received
February 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

Other clearances by Baylis Medical Co., Inc.

  • K122926 — SUREFLEX STEERABLE GUIDING SHEATH KIT (January 24, 2013)
  • K111523 — OSTEOCOOL (TM) RF ABLATION SYSTEM (March 13, 2012)
  • K102948 — TORFLEX TRANSSEPTAL GUIDING SHEATH (April 1, 2011)
  • K102192 — INDISCAL DIGITAL MANOMETER (February 23, 2011)
  • K101372 — DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 (August 10, 2010)
  • K101615 — POWERWIRE RADIOFREQUENCY GUIDEWIRE (July 28, 2010)
  • K101117 — LEV-OR DILATION CATHETER OTW (July 16, 2010)
  • K092877 — INDISCAL ASPIRATION DEVICE AND ACCESSORIES (November 17, 2009)
  • K092337 — PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS (October 16, 2009)
  • K073326 — NRG TRANSSEPTAL NEEDLE (May 28, 2008)

Other clearances for product code GXD

  • K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (August 7, 2025)
  • K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADV (August 14, 2024)
  • K232632 — Racz Neurostat RF Generator (May 24, 2024)
  • K231675 — OneRF Ablation System (December 6, 2023)
  • K220122 — APEX 6 (March 15, 2023)
  • K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS (January 21, 2022)
  • K201610 — IonicRF Generator (October 21, 2020)
  • K192491 — Coolief Radiofrequency Generator (CRG) System (February 21, 2020)
  • K181864 — Polaris RF Ablation System (January 2, 2019)
  • K171143 — Relievant Medsystems RF Generator (August 18, 2017)

FDA data resources