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FDA 510(k)

NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY

K-Number: K905181 · 1991-03-06

ApplicantMeadox Surgimed, Inc.
Decision Date1991-03-06
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Surgimed, Inc.. It received FDA 510(k) clearance on 1991-03-06 under 510(k) number K905181. 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 NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY?

NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY is a medical device that received FDA 510(k) clearance on 1991-03-06. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K905181.

When did NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY receive FDA 510(k) clearance?

NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY received FDA 510(k) clearance on 1991-03-06, under 510(k) number K905181.

Who is the listed applicant for NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY?

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

What is the FDA product code for NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY?

The FDA product code for NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY is EZN.

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Other records listing Meadox Surgimed, 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.

K944143MS CLASSIQUE BALLOON CATHETERK945061NOPROFILE OLBERT CATHETER SYSTEMK942382MS AMPLATZ EXTRA STIFF GUIDE WIREK930201ACECUT SUTOMATIC BIOPSY SYSTEMK911635MEADOX(R) SURGIMED(R) BIOPSY GUN IIK904582QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE

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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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