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FDA 510(k)

DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES

K-Number: K090979 · 2009-05-28

ApplicantEncision, Inc.
Decision Date2009-05-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Encision, Inc.. It received FDA 510(k) clearance on 2009-05-28 under 510(k) number K090979. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES?

DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES is a medical device that received FDA 510(k) clearance on 2009-05-28. The listed applicant is Encision, Inc.. The 510(k) number is K090979.

When did DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES receive FDA 510(k) clearance?

DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES received FDA 510(k) clearance on 2009-05-28, under 510(k) number K090979.

Who is the listed applicant for DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES?

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 DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES?

The FDA product code for DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES is GCJ.

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Other records listing Encision, Inc. as applicant

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Related Devices (Code: GCJ)

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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