K233524

Sleeved 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)

510(k) number: K233524
Device name: Sleeved 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)
Applicant: Hollister Incorporated IL · US
Product code: EZD — Catheter, Straight
Decision date: 2024-05-03
Date received: 2023-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Gastroenterology, Urology

PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K233524.pdf

Official FDA record: K233524

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.