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FDA 510(k)

TAMPONADE BALLOON CUFF

K-Number: K833859 · 1984-01-03

ApplicantAmerican Endoscopy, Inc.
Decision Date1984-01-03
Product CodeGCP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TAMPONADE BALLOON CUFF 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 1984-01-03 under 510(k) number K833859. The device is classified under product code GCP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAMPONADE BALLOON CUFF?

TAMPONADE BALLOON CUFF is a medical device that received FDA 510(k) clearance on 1984-01-03. The listed applicant is American Endoscopy, Inc.. The 510(k) number is K833859.

When did TAMPONADE BALLOON CUFF receive FDA 510(k) clearance?

TAMPONADE BALLOON CUFF received FDA 510(k) clearance on 1984-01-03, under 510(k) number K833859.

Who is the listed applicant for TAMPONADE BALLOON CUFF?

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 TAMPONADE BALLOON CUFF?

The FDA product code for TAMPONADE BALLOON CUFF is GCP.

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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 MONITORK833491ENDO BITE BLOCKK840818BIOPSY FORCEPSK833492PERCUTANEOUS ENDOSCOPIC GASTROSCOPYK832458AUTOMATIC ENDOSCOPE

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Related Devices (Code: GCP)

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.

K954614EOS BRAND DISPOSABLE PROCTOSCOPENorth Eos Industries, Inc.K896505PORGES UNIVERSAL HANDLESPorges Corp.K896008MODEL 6500 MERCURY ARC LIGHT SOURCEMedical Dynamics, Inc.K862424STEERABLE CATHETER SYSTEMEndovationsK860103MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVEEndotherapeuticsK843683MODULAR FIBERSCOPE SYSTEMReichert Scientific Instruments

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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