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FDA 510(k)

Female IC (Not Finalized)

K-Number: K213575 · 2022-09-13

ApplicantHollister Incorporated
Decision Date2022-09-13
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Female IC (Not Finalized) is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2022-09-13 under 510(k) number K213575. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Female IC (Not Finalized)?

Female IC (Not Finalized) is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Hollister Incorporated. The 510(k) number is K213575.

When did Female IC (Not Finalized) receive FDA 510(k) clearance?

Female IC (Not Finalized) received FDA 510(k) clearance on 2022-09-13, under 510(k) number K213575.

Who is the listed applicant for Female IC (Not Finalized)?

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 Female IC (Not Finalized)?

The FDA product code for Female IC (Not Finalized) is EZD.

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.

NCT07460323Study of TRE Seals on Early Post-operative SubjectsRECRUITINGNCT07714694Consumer Evaluation of an Investigational Intermittent CatheterRECRUITING

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 ICK211436Intermittent Catheter (Not Finalized)K193148VaPro Plus Pocket, VaPro Plus

View all 11 devices →

Related Devices (Code: EZD)

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.

K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister IncorporatedK260999LoFric Elle ProWellspect AB

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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