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GAP — Suture, Nonabsorbable, Silk Class II

FDA Device Classification

Classification Details

Product Code
GAP
Device Class
Class II
Regulation Number
878.5030
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241486covidienSofsilk™ Coated Braided Silk SutureDecember 3, 2024
K222944safepath medicalSafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide SuturOctober 18, 2024
K232355shandong haidike medical product coNon absorbable Surgical Silk SutureJanuary 16, 2024
K221767huaian seamen medical technology coSurgical Sutures with or without NeedleJuly 31, 2023
K180701safepath medicalSafePath Suturing SystemJune 25, 2018
K172149m/s. meril endo surgery private limitedFILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non AbsorbablOctober 20, 2017
K162396teleflexmedicalSILK Surgical SutureNovember 23, 2016
K160623m/s. meril endo surgery private limitedFILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non AbsorbablMay 31, 2016
K080684foosin medical suppliesWG-SURGICAL SUTURES WITH NEEDLEJune 9, 2008
K071111arrow intlNON-ABSORBABLE SILK SUTUREJuly 17, 2007
K053638maniMANI NEEDLE & SUTURE PACK (SILK)May 19, 2006
K041514sutures india private limitedTRUESILK NON-ABSORBABLE SILK SURGICAL SUTUREJune 3, 2005
K042282united medical industries co.UNISILKDecember 1, 2004
K024091aurolabSILK SUTURESFebruary 28, 2003
K023029demetechDEMETECH SILK NONABSORBABLE SUTURENovember 25, 2002
K020901serral, s.a. de c.vSERRALSILKApril 26, 2002
K012124johnson and johnson medical (china)MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USPSeptember 19, 2001
K003001gramsmedGRAMS SILK NONABSORBABLE SUTUREDecember 15, 2000
K001184cp medicalSILK, NONABSORBABLE, SURGICAL SUTURES, USPJune 23, 2000
K000541arc medical supplies (beijing) coSILK NONABSORBABLE SURGICAL SUTURES, USPApril 28, 2000