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FDA 510(k)

Onli Intermittent Catheter

K-Number: K163179 · 2017-01-26

ApplicantHollister Incorporated
Decision Date2017-01-26
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Onli Intermittent Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K163179. 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 Onli Intermittent Catheter?

Onli Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Hollister Incorporated. The 510(k) number is K163179.

When did Onli Intermittent Catheter receive FDA 510(k) clearance?

Onli Intermittent Catheter received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163179.

Who is the listed applicant for Onli Intermittent Catheter?

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

What is the FDA product code for Onli Intermittent Catheter?

The FDA product code for Onli Intermittent Catheter is GBM.

Related Clinical Trials

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.

NCT07714694Consumer Evaluation of an Investigational Intermittent CatheterRECRUITINGNCT07460323Study of TRE Seals on Early Post-operative SubjectsRECRUITING

Other records listing Hollister Incorporated 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.

K253295Coude Sleeved IC; Coude Plus Sleeved ICK251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)K220667Sleeved ICK213575Female IC (Not Finalized)K211436Intermittent Catheter (Not Finalized)

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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

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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