Cleared Traditional

K232934 - Sunsphere

K232934 is an FDA 510(k) clearance for Sunsphere, manufactured by Hangzhou Yangshun Medical Technology Co.,Ltd. The device is a Class 2 Obstetrics & Gynecology device with product code KRD cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K232934 · Hangzhou Yangshun Medical Technology Co.,Ltd · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
253d
Days
Class 2
Risk

K232934 is an FDA 510(k) clearance for the Sunsphere. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Hangzhou Yangshun Medical Technology Co.,Ltd (Hangzhou, CN). The FDA issued a Cleared decision on May 30, 2024 after a review of 253 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 870.3300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hangzhou Yangshun Medical Technology Co.,Ltd devices

FDA 510(k) Submission Details - K232934

510(k) Number K232934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2023
Decision Date May 30, 2024
Days to Decision 253 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 160d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K232934.
TEMBO Embolic System
K240873 · Instylla, Inc. · Dec 2024
ONCOZENE Microspheres
K242794 · Varian Medical Systems, Inc. · Oct 2024
OBSIDIO™ Conformable Embolic
K242507 · Boston Scientific · Oct 2024
Siege Vascular Plug (SVP2.5-0.021)
K240261 · Merit Medical Systems, Inc. · May 2024
Easi-Vue® embolic microspheres System
K234123 · Abk Biomedical, Inc. · Feb 2024
UniPearls® Embolic Microspheres
K231554 · Suzhou Haowei Medical Technology Co., Ltd. · Nov 2023