FDA.reportPublic FDA data

510(k) K232355

Device
Non absorbable Surgical Silk Suture
Applicant
Shandong Haidike Medical Product Co., Ltd.
510(k) number
K232355
Product code
GAP
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-16
Date received
2023-08-07
Regulation
878.5030
Classification name
Suture, Nonabsorbable, Silk
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yan Wang
Address
Tianfu Rd., Dongcheng District, Shan County Heze CN 274300 274300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241486Sofsilk™ Coated Braided Silk SutureCovidien2024-12-03
K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.2024-10-18
K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.2023-07-31
K180701SafePath Suturing SystemSafepath Medical, Inc.2018-06-25
K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.2017-10-20
K162396SILK Surgical SutureTeleflexmedical, Inc.2016-11-23
K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited.2016-05-31
K080684WG-SURGICAL SUTURES WITH NEEDLEFoosin Medical Supplies, Inc.2008-06-09
K071111NON-ABSORBABLE SILK SUTUREArrow Intl., Inc.2007-07-17
K053638MANI NEEDLE & SUTURE PACK (SILK)Mani, Inc.2006-05-19
K041514TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURESutures India Private Limited2005-06-03
K042282UNISILKUnited Medical Industries Co. , Ltd.2004-12-01
K024091SILK SUTURESAurolab2003-02-28
K023029DEMETECH SILK NONABSORBABLE SUTUREDemetech Corp.2002-11-25
K020901SERRALSILKSerral, S.A. DE C.V.2002-04-26