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FDA 510(k)

THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS

K-Number: K011055 · 2001-06-06

ApplicantGo Medical Industries Pty. , Ltd.
Decision Date2001-06-06
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS is the device name listed in this FDA 510(k) record. The listed applicant is Go Medical Industries Pty. , Ltd.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K011055. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS?

THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Go Medical Industries Pty. , Ltd.. The 510(k) number is K011055.

When did THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS receive FDA 510(k) clearance?

THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS received FDA 510(k) clearance on 2001-06-06, under 510(k) number K011055.

Who is the listed applicant for THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS?

The FDA 510(k) record lists Go Medical Industries Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS?

The FDA product code for THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS is FCM.

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Other records listing Go Medical Industries Pty. , Ltd. 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.

K002803THE O'NEIL STERILE FIELD URINARY CATHETER KITK000263GO MEDICAL BALLOON INFUSION SYSTEMK910007SPRINGFUSOR 10RK900336V SETK895594SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLEK890400MODIFIED URINARY CATHETER INTRODUCER (UCI)

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Related Devices (Code: FCM)

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.

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, Inc.

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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