Raney Clips Kit— 510(k) K253814

Name: FDA 510(k) clearance K253814
Creator: U.S. Food and Drug Administration
Published: 2026-07-21

Substantially Equivalent

Beijing Honghugaoxiang Science and Technology Development CO

FDA 510(k) clearance K253814 for Raney Clips Kit, Substantially Equivalent on 2026-07-21. Applicant: Beijing Honghugaoxiang Science and Technology Development CO. Device class: 2.

Summary

Beijing Honghugaoxiang Science and Technology Development's Raney Clips Kit is filed under HBO, scalp clips. The record doesn't list the kit's contents.

Class II, 21 CFR 882.4150. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

The applicant filed from Beijing, China. Review took 235 calendar days (November 28, 2025 to July 21, 2026).

Clearance details

Applicant: Beijing Honghugaoxiang Science and Technology Development CO
Product code: Product code HBO
Device class: Class 2
Regulation: 21 CFR 882.4150
Advisory panel: Neurology
Date received: 2025-11-28
Decision date: 2026-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HBO

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K050044 — MEDTRONIC CLIP GUN KIT2005-02-07
K033660 — STORZ RANEY SCALP CLIP, MODEL 1-20-004-052004-01-07
K012219 — SCALPFIX CLIP SYSTEM2001-07-31
K944311 — ACRA-CUT1994-11-18
K905433 — CODMAN DISPOSABLE SCALP CLIP APPLIER1991-02-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.