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

FDA 510(k)

VaPro 2 Intermittent Catheter

K-Number: K180824 · 2018-06-22

ApplicantHollister Incorporated
Decision Date2018-06-22
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VaPro 2 Intermittent Catheter is a medical device manufactured by Hollister Incorporated. It received FDA 510(k) clearance on 2018-06-22 under approval number K180824. 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 VaPro 2 Intermittent Catheter?

VaPro 2 Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Hollister Incorporated. The 510(k) number is K180824.

When was VaPro 2 Intermittent Catheter approved by the FDA?

VaPro 2 Intermittent Catheter received FDA 510(k) clearance on 2018-06-22, under approval number K180824.

What company makes VaPro 2 Intermittent Catheter?

VaPro 2 Intermittent Catheter is manufactured by Hollister Incorporated.

What is the FDA product code for VaPro 2 Intermittent Catheter?

The FDA product code for VaPro 2 Intermittent Catheter is GBM.

Related Clinical Trials

NCT07179705 Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients RECRUITING

Other Devices by Hollister Incorporated

K163179Onli Intermittent Catheter K183253ValPro 2 Plus, VaPro 2 Plus Pocket K193148VaPro Plus Pocket, VaPro Plus K191633Infyna Chic K220667Sleeved IC K213575Female IC (Not Finalized)

View all 10 devices →

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.

↑