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FDA 510(k)

ENDO BITE BLOCK

K-Number: K833491 · 1984-04-25

ApplicantAmerican Endoscopy, Inc.
Decision Date1984-04-25
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENDO BITE BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is American Endoscopy, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K833491. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO BITE BLOCK?

ENDO BITE BLOCK is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is American Endoscopy, Inc.. The 510(k) number is K833491.

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

ENDO BITE BLOCK received FDA 510(k) clearance on 1984-04-25, under 510(k) number K833491.

Who is the listed applicant for ENDO BITE BLOCK?

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

What is the FDA product code for ENDO BITE BLOCK?

The FDA product code for ENDO BITE BLOCK is KTI.

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Other records listing American Endoscopy, 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.

K853274AMERICAN DILATATION SYSTEMK841384PROXIMA 1 PH MONITORK840818BIOPSY FORCEPSK833859TAMPONADE BALLOON CUFFK833492PERCUTANEOUS ENDOSCOPIC GASTROSCOPYK832458AUTOMATIC ENDOSCOPE

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Related Devices (Code: KTI)

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.

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm ScopesCook Ireland, Ltd.K251478ClearTip TBNA TypeFinemedix Co., Ltd.K254040LungFlow Basket CatheterFree Flow Medical, Inc.K251402LIA-1 Catheter (542-1)Leadoptik, Inc.K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc.K251664Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)Olympus Medical Systems 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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