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510(k) K092732

PROPENCIL ESU PENCIL by Bio Protech, Inc. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2009
Date Received
September 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Bio Protech, Inc.

  • K192035 — EvaQMax Smoke Evacuation System (August 29, 2019)
  • K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, (June 3, 2016)
  • K153019 — Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (March 21, 2016)
  • K143103 — PROPENCIL Smoke Pencil (July 16, 2015)
  • K142099 — CUTANEOUS ELECTRODES (November 17, 2014)
  • K111270 — REUSABLE STIMULATING ELECTRODES (September 13, 2011)
  • K100246 — MAX-IF1000 (November 24, 2010)
  • K091248 — MAXEMS, MODELS 1000 AND 2000 (November 30, 2009)
  • K092761 — PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C (November 24, 2009)
  • K083148 — TELECTRODE WET GEL ECG ELECTRODE (November 7, 2008)

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