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)

KARL STORZ Cholangiography Set

K-Number: K250927 · 2025-11-22

ApplicantKarl Storz SE & CO. KG
Decision Date2025-11-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Cholangiography Set is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2025-11-22 under approval number K250927. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ Cholangiography Set?

KARL STORZ Cholangiography Set is a medical device that received FDA 510(k) clearance on 2025-11-22. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K250927.

When was KARL STORZ Cholangiography Set approved by the FDA?

KARL STORZ Cholangiography Set received FDA 510(k) clearance on 2025-11-22, under approval number K250927.

What company makes KARL STORZ Cholangiography Set?

KARL STORZ Cholangiography Set is manufactured by Karl Storz SE & CO. KG.

What is the FDA product code for KARL STORZ Cholangiography Set?

The FDA product code for KARL STORZ Cholangiography Set is GCJ.

Other Devices by Karl Storz SE & CO. KG

K180735Endomat Select K201355Endomat Select, IBS Shaver Software, License K192090CMOS Video Rhino-Laryngoscope SSU K192523CMOS Video Esophagoscope SSU K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit K232857KARL STORZ ICG Imaging System

View all 24 devices →

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

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.

↑