Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Infyna Chic

K-Number: K191633 · 2019-07-19

ApplicantHollister Incorporated
Decision Date2019-07-19
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Infyna Chic is the device name listed in this FDA 510(k) record. The listed applicant is Hollister Incorporated. It received FDA 510(k) clearance on 2019-07-19 under 510(k) number K191633. 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 Infyna Chic?

Infyna Chic is a medical device that received FDA 510(k) clearance on 2019-07-19. The listed applicant is Hollister Incorporated. The 510(k) number is K191633.

When did Infyna Chic receive FDA 510(k) clearance?

Infyna Chic received FDA 510(k) clearance on 2019-07-19, under 510(k) number K191633.

Who is the listed applicant for Infyna Chic?

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 Infyna Chic?

The FDA product code for Infyna Chic 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.

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 ICK213575Female IC (Not Finalized)K211436Intermittent Catheter (Not Finalized)

View all 11 devices →

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.

↑