Cleared Traditional

K173871 - CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

K173871 is an FDA 510(k) clearance for CalliSpheres Embolic Microspheres, manufactured by Suzhou Hengrui Callisyn Biomedical Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K173871

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.

NAJ Device Classification - Class 2, Special Controls

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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