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FDA 510(k)

Fule Vertebroplasty Balloon Catheter

K-Number: K260203 · 2026-08-28

ApplicantBeijing Fule Science & Technology Development Co., Ltd.
Decision Date2026-08-28
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fule Vertebroplasty Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2026-08-28 under 510(k) number K260203. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fule Vertebroplasty Balloon Catheter?

Fule Vertebroplasty Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-08-28. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K260203.

When did Fule Vertebroplasty Balloon Catheter receive FDA 510(k) clearance?

Fule Vertebroplasty Balloon Catheter received FDA 510(k) clearance on 2026-08-28, under 510(k) number K260203.

Who is the listed applicant for Fule Vertebroplasty Balloon Catheter?

The FDA 510(k) record lists Beijing Fule Science & Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fule Vertebroplasty Balloon Catheter?

The FDA product code for Fule Vertebroplasty Balloon Catheter is HRX.

Other records listing Beijing Fule Science & Technology Development Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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