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Bipolard Polypectomy System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901302

by Medical Devices Inc.

Identifiers

510(k) Number
K901302 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bipolard Polypectomy System is an electrosurgical system comprising a generator, bipolar polypectomy snare, and electrosurgical knife. The generator delivers bipolar high-frequency current for tissue cutting and coagulation, with output controlled via a two-pedal mechanism.

The device is supplied as a system for use in electrosurgical procedures. It received FDA 510(k) clearance under K901302 on June 6, 1990, and is classified under product code GEI. The system is intended for general and plastic surgery applications as indicated by the advisory committee classification.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BIPOLARD POLYPECTOMY SYSTEM (TM) (K901302) — FDA 510 (k) | Innolitics, 510 (k) Premarket Notification, MEDICAL DEVICES (PVT) LTD. FDA Filings - FDA.report, Electrosurgical System (Electrosurgical Generator with Bipolar ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Devices Inc.
FDA Applicant
Medical Devices, Inc.

Sources (1)

  • FDA 510(k) K901302 24 fields · synced Sep 21, 2026