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510(k) K031950

BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD by Baylis Medical Co., Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2003
Date Received
June 24, 2003
Clearance Type
Abbreviated
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 Baylis Medical Co., Inc.

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  • 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)

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