510(k) K092761

PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C by Bio Protech, Inc. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 24, 2009
Date Received: September 9, 2009
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 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)
K092732 — PROPENCIL ESU PENCIL (November 25, 2009)
K083148 — TELECTRODE WET GEL ECG ELECTRODE (November 7, 2008)

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