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FDA 510(k)

SUCTION IRRIGATION ELECTRODES AND ADAPTERS

K-Number: K100711 · 2010-06-09

ApplicantEncision, Inc.
Decision Date2010-06-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUCTION IRRIGATION ELECTRODES AND ADAPTERS is the device name listed in this FDA 510(k) record. The listed applicant is Encision, Inc.. It received FDA 510(k) clearance on 2010-06-09 under 510(k) number K100711. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION IRRIGATION ELECTRODES AND ADAPTERS?

SUCTION IRRIGATION ELECTRODES AND ADAPTERS is a medical device that received FDA 510(k) clearance on 2010-06-09. The listed applicant is Encision, Inc.. The 510(k) number is K100711.

When did SUCTION IRRIGATION ELECTRODES AND ADAPTERS receive FDA 510(k) clearance?

SUCTION IRRIGATION ELECTRODES AND ADAPTERS received FDA 510(k) clearance on 2010-06-09, under 510(k) number K100711.

Who is the listed applicant for SUCTION IRRIGATION ELECTRODES AND ADAPTERS?

The FDA 510(k) record lists Encision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUCTION IRRIGATION ELECTRODES AND ADAPTERS?

The FDA product code for SUCTION IRRIGATION ELECTRODES AND ADAPTERS is GEI.

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Other records listing Encision, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201018Encision AEM enTouch 2X ScissorK131949AEM DISPOSABLE SUCTION IRRIGATION ELECTRODESK122383EM3 AEM MONITOR AEM CONNECTORSK122580AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIESK093622AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015K091074AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES

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Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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