Cleared Traditional

K173871 - CalliSpheres Embolic Microspheres

K173871 is the FDA 510(k) clearance for CalliSpheres Embolic Microspheres by Suzhou Hengrui Callisyn Biomedical Co., Ltd.. It is a Class 2 Obstetrics & Gynecology device (product code NAJ) cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K173871 · Suzhou Hengrui Callisyn Biomedical Co., Ltd. · Obstetrics & Gynecology device
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Sep 2018
Decision
271d
Days
Class 2
Risk

K173871 is an FDA 510(k) clearance for the CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres. Classified as Agents, Embolic, For Treatment Of Uterine Fibroids (product code NAJ), Class II - Special Controls.

Submitted by Suzhou Hengrui Callisyn Biomedical Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on September 17, 2018 after a review of 271 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 Suzhou Hengrui Callisyn Biomedical Co., Ltd. devices

Submission Details

510(k) Number K173871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2017
Decision Date September 17, 2018
Days to Decision 271 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 160d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
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.

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