Cleared Traditional

Kyphoplasty Balloon Dilatation Catheters

K252458 · Shanghai Lange Medtech Co., Ltd. · Orthopedic

Nov 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K252458 is an FDA 510(k) clearance for the Kyphoplasty Balloon Dilatation Catheters, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Shanghai Lange Medtech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 3, 2025, 90 days after receiving the submission on August 5, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K252458 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2025
Decision Date	November 03, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).