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FDA 510(k)

PRO PULSE SYRINGE IRRIGATION SYSTEM

K-Number: K941385 · 1994-06-09

ApplicantGiesy Consultants, Inc.
Decision Date1994-06-09
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRO PULSE SYRINGE IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Giesy Consultants, Inc.. It received FDA 510(k) clearance on 1994-06-09 under 510(k) number K941385. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO PULSE SYRINGE IRRIGATION SYSTEM?

PRO PULSE SYRINGE IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-06-09. The listed applicant is Giesy Consultants, Inc.. The 510(k) number is K941385.

When did PRO PULSE SYRINGE IRRIGATION SYSTEM receive FDA 510(k) clearance?

PRO PULSE SYRINGE IRRIGATION SYSTEM received FDA 510(k) clearance on 1994-06-09, under 510(k) number K941385.

Who is the listed applicant for PRO PULSE SYRINGE IRRIGATION SYSTEM?

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

What is the FDA product code for PRO PULSE SYRINGE IRRIGATION SYSTEM?

The FDA product code for PRO PULSE SYRINGE IRRIGATION SYSTEM is LJH.

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Related Devices (Code: LJH)

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.

K254111Irrigation/Urology SetsB.Braun Medical, Inc.K162992Karl Storz UROMAT E.A.S.I.Karl Storz Endoscopy America, Inc.K070873AMSURE BLADDER IRRIGATION SETAmsino Intl., Inc.K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K063700SPYGLASS IRRIGATION SYSTEMMedical Scientific, Inc.K062551NEXUS IRRIGATION TUBING SETNexus Medical, LLC

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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