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FDA 510(k)

RETRIEVAL BALLOONS

K-Number: K821818 · 1982-09-24

ApplicantAmerican Endoscopy, Inc.
Decision Date1982-09-24
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RETRIEVAL BALLOONS 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 1982-09-24 under 510(k) number K821818. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETRIEVAL BALLOONS?

RETRIEVAL BALLOONS is a medical device that received FDA 510(k) clearance on 1982-09-24. The listed applicant is American Endoscopy, Inc.. The 510(k) number is K821818.

When did RETRIEVAL BALLOONS receive FDA 510(k) clearance?

RETRIEVAL BALLOONS received FDA 510(k) clearance on 1982-09-24, under 510(k) number K821818.

Who is the listed applicant for RETRIEVAL BALLOONS?

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 RETRIEVAL BALLOONS?

The FDA product code for RETRIEVAL BALLOONS is KOD.

Related Clinical Trials

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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 FORCEPSK833859TAMPONADE BALLOON CUFFK833492PERCUTANEOUS ENDOSCOPIC GASTROSCOPY

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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