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FDA 510(k)

NOPROFILE OLBERT CATHETER SYSTEM

K-Number: K945061 · 1995-03-09

ApplicantMeadox Surgimed, Inc.
Decision Date1995-03-09
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NOPROFILE OLBERT CATHETER SYSTEM 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 1995-03-09 under 510(k) number K945061. 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 NOPROFILE OLBERT CATHETER SYSTEM?

NOPROFILE OLBERT CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 1995-03-09. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K945061.

When did NOPROFILE OLBERT CATHETER SYSTEM receive FDA 510(k) clearance?

NOPROFILE OLBERT CATHETER SYSTEM received FDA 510(k) clearance on 1995-03-09, under 510(k) number K945061.

Who is the listed applicant for NOPROFILE OLBERT CATHETER SYSTEM?

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 NOPROFILE OLBERT CATHETER SYSTEM?

The FDA product code for NOPROFILE OLBERT CATHETER SYSTEM is KOD.

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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 CATHETERK942382MS AMPLATZ EXTRA STIFF GUIDE WIREK930201ACECUT SUTOMATIC BIOPSY SYSTEMK911635MEADOX(R) SURGIMED(R) BIOPSY GUN IIK905181NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGYK904582QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE

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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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