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FDA 510(k)

MENTOR PERCUTANEOUS RENAL DILATOR SET

K-Number: K850355 · 1985-03-12

ApplicantMentor Corp.
Decision Date1985-03-12
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MENTOR PERCUTANEOUS RENAL DILATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1985-03-12 under 510(k) number K850355. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR PERCUTANEOUS RENAL DILATOR SET?

MENTOR PERCUTANEOUS RENAL DILATOR SET is a medical device that received FDA 510(k) clearance on 1985-03-12. The listed applicant is Mentor Corp.. The 510(k) number is K850355.

When did MENTOR PERCUTANEOUS RENAL DILATOR SET receive FDA 510(k) clearance?

MENTOR PERCUTANEOUS RENAL DILATOR SET received FDA 510(k) clearance on 1985-03-12, under 510(k) number K850355.

Who is the listed applicant for MENTOR PERCUTANEOUS RENAL DILATOR SET?

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

What is the FDA product code for MENTOR PERCUTANEOUS RENAL DILATOR SET?

The FDA product code for MENTOR PERCUTANEOUS RENAL DILATOR SET is EZN.

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Other records listing Mentor Corp. 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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Related Devices (Code: EZN)

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.

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook IncorporatedK180756Safety Wire Guide IntroducerCook Incorporated

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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