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FDA 510(k)

CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE

K-Number: K011848 · 2001-09-11

ApplicantCircon Video
Decision Date2001-09-11
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 2001-09-11 under 510(k) number K011848. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE?

CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE is a medical device that received FDA 510(k) clearance on 2001-09-11. The listed applicant is Circon Video. The 510(k) number is K011848.

When did CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE receive FDA 510(k) clearance?

CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE received FDA 510(k) clearance on 2001-09-11, under 510(k) number K011848.

Who is the listed applicant for CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE?

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

What is the FDA product code for CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE?

The FDA product code for CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE is FFK.

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Other records listing Circon Video as applicant

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K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,K011876DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2K011849MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROSK012929FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735K012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPEK012925DUR-8, MODELS DUR-8

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Related Devices (Code: FFK)

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.

K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbHK202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.

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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