Identifiers
- 510(k) Number
- K192684 FDA 510(k)
- FDA Product Code
- NOY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5550 FDA 510(k)
- Regulation Number
- 876.5550 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
HydroPearl Microspheres are agents, embolic, for treatment of benign prostatic hyperplasia. They are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel.
The device is supplied in a variety of diameters. It is regulated under FDA 510(k) clearance K192684, with product code NOY and regulation number 876.5550. The device is classified as Class II and is indicated for use in gastroenterology and urology specialties.
Frequently asked questions
What is HydroPearl Microspheres used for?
HydroPearl Microspheres are embolic agents indicated for the treatment of benign prostatic hyperplasia (BPH). They are designed to occlude prostatic arteries to reduce blood flow to the gland, thereby alleviating urinary symptoms associated with BPH. This use is specific to urology and gastroenterology specialties as defined in the device’s regulatory filing.
How is HydroPearl Microspheres supplied and is it sterile?
HydroPearl Microspheres are supplied as a pre-formed, compressible, spherical hydrogel agent in a variety of diameters. The device is provided in a sterile condition, ready for clinical use, and is intended for single-use only. Sterility is maintained through the manufacturer’s validated packaging and processing controls as part of the FDA 510(k) submission.
What sizes or models are available for HydroPearl Microspheres?
The device is supplied in a variety of diameters, though specific size ranges are not detailed in the provided data. The microspheres are precisely calibrated and spherical, allowing for predictable embolic behavior. Clinicians should refer to the product labeling or manufacturer’s instructions for use for the exact diameter options available for selection based on procedural needs.
Is HydroPearl Microspheres reusable or single-use?
HydroPearl Microspheres are intended for single-use only. As a sterile, pre-formed embolic agent delivered via catheter, reuse would compromise sterility, structural integrity, and safety. The device’s design and regulatory clearance under FDA 510(k) K192684 support single-patient, single-procedure use to prevent cross-contamination and ensure consistent performance.
What regulatory pathway was used for HydroPearl Microspheres?
HydroPearl Microspheres received market authorization through the FDA 510(k) pathway, specifically under clearance K192684. The device was found substantially equivalent to a predicate device, with product code NOY and regulation number 876.5550. It is classified as a Class II medical device, and this pathway confirms its safety and effectiveness for the intended use in treating benign prostatic hyperplasia.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Summary of Safety and Clinical Performance For HydroPearl™ Microspheres ..., HYDROPEARL™ Microspheres | Terumo Interventional Systems, HydroPearl Microspheres, HydroPearl Microspheres by MICROVENTION, INC ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192684 | Class II | Active |
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Manufacturer
- Manufacturer
- Microvention Inc.
- FDA Applicant
- MicroVention, Inc.
Sources (1)
- FDA 510(k) K192684 24 fields · synced Sep 21, 2026