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FDA 510(k)

Intermittent Catheter (Not Finalized)

K-Number: K211436 · 2022-01-27

ApplicantHollister Incorporated
Decision Date2022-01-27
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Intermittent Catheter (Not Finalized) is a medical device manufactured by Hollister Incorporated. It received FDA 510(k) clearance on 2022-01-27 under approval number K211436. 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 Intermittent Catheter (Not Finalized)?

Intermittent Catheter (Not Finalized) is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Hollister Incorporated. The 510(k) number is K211436.

When was Intermittent Catheter (Not Finalized) approved by the FDA?

Intermittent Catheter (Not Finalized) received FDA 510(k) clearance on 2022-01-27, under approval number K211436.

What company makes Intermittent Catheter (Not Finalized)?

Intermittent Catheter (Not Finalized) is manufactured by Hollister Incorporated.

What is the FDA product code for Intermittent Catheter (Not Finalized)?

The FDA product code for Intermittent Catheter (Not Finalized) is GBM.

Related Clinical Trials

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Other Devices by Hollister Incorporated

K163179Onli Intermittent Catheter K183253ValPro 2 Plus, VaPro 2 Plus Pocket K180824VaPro 2 Intermittent Catheter K193148VaPro Plus Pocket, VaPro Plus K191633Infyna Chic K220667Sleeved IC

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Related Devices (Code: GBM)

K161672SpeediCath Flex CoudeColoplast Corp. K160795United Urologics Intermittent CatheterRobling Medical K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc. K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook Incorporated K163179Onli Intermittent CatheterHollister Incorporated K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister 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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