Cleared Traditional

Sunsphere (K232934) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232934 · Hangzhou Yangshun Medical Technology Co.,Ltd · Obstetrics & Gynecology device
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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

Submission Details

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.

Device Classification

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 70
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