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FDA 510(k)

BITE BLOCK

K-Number: K954352 · 1996-01-25

ApplicantUnited States Endoscopy Group, Inc.
Decision Date1996-01-25
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BITE BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 1996-01-25 under 510(k) number K954352. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BITE BLOCK?

BITE BLOCK is a medical device that received FDA 510(k) clearance on 1996-01-25. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K954352.

When did BITE BLOCK receive FDA 510(k) clearance?

BITE BLOCK received FDA 510(k) clearance on 1996-01-25, under 510(k) number K954352.

Who is the listed applicant for BITE BLOCK?

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

What is the FDA product code for BITE BLOCK?

The FDA product code for BITE BLOCK is JXL.

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Related Devices (Code: JXL)

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.

K221469PATI (Protector Against Tongue Injury)Neurovice, LLCK201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta CorporationK172978SurgeoBiteSurgovations, LLCK050188EPIGUARDEpisafe Medical Devices, Ltd.K992269VENTIL-A ORAL PROTECTORSomatics, Inc.K960663UNIVERSAL BITE BLOCKB&B Medical Technologies, Inc.

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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