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The Tracker / October 2026 / K262674

510(k) cleared

Giranel Guiding Sheath Set

Kossel Medtech (Suzhou) Co., Ltd. · Oct 15, 2026 · K262674

FDA cleared the Giranel Guiding Sheath Set from Kossel Medtech (Suzhou) Co., Ltd. on Oct 15, 2026 under K262674, a traditional 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 30, 2026. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

Kossel Medtech (Suzhou) Co., Ltd. has one other decision in the tracker over the last 12 months: K254212 (NC PTA Balloon Dilatation Catheter).

Questions & Answers

What did FDA clear under K262674?

K262674 is the FDA 510(k) for Giranel Guiding Sheath Set, submitted by Kossel Medtech (Suzhou) Co., Ltd.. FDA's decision date was Oct 15, 2026, under product code DYB (Introducer, Catheter).

Who makes the Giranel Guiding Sheath Set?

Kossel Medtech (Suzhou) Co., Ltd., based in Suzhou New District, is the applicant of record for K262674.

How long did the K262674 review take?

FDA received the submission on Jul 30, 2026 and issued its decision on Oct 15, 2026, 77 days later.

← All decisions in October 2026

Sources