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FDA 510(k)

URETERAL STONE EXTRACTOR CATHETER

K-Number: K831244 · 1983-06-17

ApplicantAmerican Edwards Laboratories
Decision Date1983-06-17
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETERAL STONE EXTRACTOR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1983-06-17 under 510(k) number K831244. 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 URETERAL STONE EXTRACTOR CATHETER?

URETERAL STONE EXTRACTOR CATHETER is a medical device that received FDA 510(k) clearance on 1983-06-17. The listed applicant is American Edwards Laboratories. The 510(k) number is K831244.

When did URETERAL STONE EXTRACTOR CATHETER receive FDA 510(k) clearance?

URETERAL STONE EXTRACTOR CATHETER received FDA 510(k) clearance on 1983-06-17, under 510(k) number K831244.

Who is the listed applicant for URETERAL STONE EXTRACTOR CATHETER?

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

What is the FDA product code for URETERAL STONE EXTRACTOR CATHETER?

The FDA product code for URETERAL STONE EXTRACTOR CATHETER is KOD.

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Other records listing American Edwards Laboratories 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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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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