Skip to content

Kyphoplasty Balloon Dilatation Catheters S01-1615

by Shanghai Lange Medtech Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06937321301001 UDI-DI Date18 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Kyphoplasty Balloon Dilatation Catheters
Generic Name
Inflatable bone tamp
Model / Reference
S01-1615
Primary DI / UDI-DI
06937321301001
510(k) Number
FDA Product Code
HRX, HXG
GMDN Term
Inflatable bone tamp
Device Class
Class II
Regulation Number
888.1100, 888.4540
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252458)

Other devices from Shanghai Lange Medtech Co., Ltd.

See all devices from Shanghai Lange Medtech Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No