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FDA 510(k)

O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER

K-Number: K993651 · 1999-12-23

ApplicantSc Hennig Enterprises Europe Srl
Decision Date1999-12-23
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sc Hennig Enterprises Europe Srl. It received FDA 510(k) clearance on 1999-12-23 under 510(k) number K993651. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER?

O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER is a medical device that received FDA 510(k) clearance on 1999-12-23. The listed applicant is Sc Hennig Enterprises Europe Srl. The 510(k) number is K993651.

When did O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER receive FDA 510(k) clearance?

O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER received FDA 510(k) clearance on 1999-12-23, under 510(k) number K993651.

Who is the listed applicant for O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER?

The FDA 510(k) record lists Sc Hennig Enterprises Europe Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER?

The FDA product code for O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER is GBM.

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Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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