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510(k) K253814

Device
Raney Clips Kit
Applicant
Beijing Honghugaoxiang Science and Technology Development CO
510(k) number
K253814
Product code
HBO
Decision
Substantially Equivalent (SESE)
Decision date
2026-07-21
Date received
2025-11-28
Regulation
882.4150
Classification name
Clip, Scalp
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Zichen Jia
Address
5 Bldg. W. Side, #3, Tiangui St., Zhongguancun Science Park Daxing Biomedical Industry Base, Daxing District Beijing CN 102600 102600

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HBO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050044MEDTRONIC CLIP GUN KITMedtronic Neurosurgery2005-02-07
K033660STORZ RANEY SCALP CLIP, MODEL 1-20-004-05Rudolf Storz GmbH2004-01-07
K012219SCALPFIX CLIP SYSTEMAesculap, Inc.2001-07-31
K944311ACRA-CUTAcra Cut, Inc.1994-11-18
K905433CODMAN DISPOSABLE SCALP CLIP APPLIERCodman & Shurtleff, Inc.1991-02-21
K896723CLIP GUN WITH RANEY TYPE SCALP CLIPSOmni Medical Designs1990-03-23
K894778CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIERCodman & Shurtleff, Inc.1989-12-06
K890443CASPAR SCALP CLIP, APPLIERAesculap Instruments Corp.1989-06-15
K883963RANEY AND LEROY-RANEY SCALP CLIPNew England Surgical Instrument Corp.1988-10-07
K881265RANEY CLIPSZimmer, Inc.1988-05-31