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FDA 510(k)

BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY

K-Number: K915816 · 1992-03-27

ApplicantGi Supply
Decision Date1992-03-27
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply. It received FDA 510(k) clearance on 1992-03-27 under 510(k) number K915816. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY?

BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY is a medical device that received FDA 510(k) clearance on 1992-03-27. The listed applicant is Gi Supply. The 510(k) number is K915816.

When did BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY receive FDA 510(k) clearance?

BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY received FDA 510(k) clearance on 1992-03-27, under 510(k) number K915816.

Who is the listed applicant for BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY?

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

What is the FDA product code for BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY?

The FDA product code for BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY is EOQ.

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Other records listing Gi Supply 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.

K191923EverLift Submucosal Lifting AgentK031360GI SUPPLY BILIARY STENTK012411HP-ONEK970187RUNYON LARGE VOLUME PARACENTESIS KITK970186GI SUPPLY PARACENTESIS PUMPK944903HP-FAST

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Related Devices (Code: EOQ)

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.

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/SK2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

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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