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)

Giranel Guiding Sheath Set

K-Number: K262674 · 2026-10-15

ApplicantKossel Medtech (Suzhou) Co., Ltd.
Decision Date2026-10-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Giranel Guiding Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Kossel Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-10-15 under 510(k) number K262674. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Giranel Guiding Sheath Set?

Giranel Guiding Sheath Set is a medical device that received FDA 510(k) clearance on 2026-10-15. The listed applicant is Kossel Medtech (Suzhou) Co., Ltd.. The 510(k) number is K262674.

When did Giranel Guiding Sheath Set receive FDA 510(k) clearance?

Giranel Guiding Sheath Set received FDA 510(k) clearance on 2026-10-15, under 510(k) number K262674.

Who is the listed applicant for Giranel Guiding Sheath Set?

The FDA 510(k) record lists Kossel Medtech (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Giranel Guiding Sheath Set?

The FDA product code for Giranel Guiding Sheath Set is DYB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Kossel Medtech (Suzhou) Co., Ltd. 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.

K254212NC PTA Balloon Dilatation CatheterK231402HP PTA Balloon Dilatation CatheterK221245PTA Balloon Dilatation CatheterK211349Selebrek PTCA Balloon Dilatation CatheterK211393Selethru(TM) NC PTCA Balloon Dilatation CatheterK182699Selethru PTCA Balloon Dilatation Catheter

View all 7 devices →

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

↑