Cleared Traditional

K262674 - Giranel Guiding Sheath Set

K262674 is an FDA 510(k) clearance for Giranel Guiding Sheath Set, manufactured by Kossel Medtech (Suzhou) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K262674 · Kossel Medtech (Suzhou) Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
77d
Days
Class 2
Risk

K262674 is an FDA 510(k) clearance for the Giranel Guiding Sheath Set. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Kossel Medtech (Suzhou) Co., Ltd. (Suzhou New District, CN). The FDA issued a Cleared decision on October 15, 2026 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262674

510(k) Number K262674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2026
Decision Date October 15, 2026
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 706
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K262674 · Giranel Guiding Sheath Set
Download PDF FDA Summary Kossel Medtech (Suzho…