FDA.report

510(k) K221744

Device
STRATAFIX? Spiral MONOCRYL? Plus Knotless Tissue Control Device
Applicant
ETHICON, Inc.
510(k) number
K221744
Product code
GAM
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-15
Date received
2022-06-16
Regulation
878.4493
Classification name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Jenny Wang
Address
1000 Us-202 Raritan NJ US 08869 08869

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
30705031470099STRATAFIXETHICON, LLC2023-07-06
30705031470082STRATAFIXETHICON, LLC2023-07-06
30705031470075STRATAFIXETHICON, LLC2023-07-06
30705031470068STRATAFIXETHICON, LLC2023-07-06
30705031470051STRATAFIXETHICON, LLC2023-07-06
30705031470044STRATAFIXETHICON, LLC2023-07-06
30705031470037STRATAFIXETHICON, LLC2023-07-06
30705031470020STRATAFIXETHICON, LLC2023-07-06
30705031470013STRATAFIXETHICON, LLC2023-07-06
30705031470006STRATAFIXETHICON, LLC2023-07-06
30705031469994STRATAFIXETHICON, LLC2023-07-06
30705031469987STRATAFIXETHICON, LLC2023-07-06
30705031469970STRATAFIXETHICON, LLC2023-07-06
30705031469963STRATAFIXETHICON, LLC2023-07-06
30705031469956STRATAFIXETHICON, LLC2023-07-06

Other 510(k) Records For Product Code GAM

510(k)DeviceApplicantDecision date
K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.2026-02-06
K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.2025-12-22
K253620TroClose 1200Gordian Surgical, Ltd.2025-12-16
K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V2025-10-03
K233265Monotime and Optime RPeters Surgical2024-10-11
K232372Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)Peters Surgical2024-07-12
K221527StitchKitOrigami Surgical Inc .2023-02-14
K212810MONOFIX PGCL, knotless wound closure deviceSamyang Holdings Corp., Ltd.2022-08-05
K211792StitchKitOrigami Surgical Inc .2021-07-16
K202950StitchKit COMBOOrigami Surgical2021-02-23
K201996Monocryl Plus Antibacterial SutureETHICON, Inc.2020-12-21
K200392REXSINSm Eng Co., Ltd.2020-07-07
K200140Silhouette InstaliftSilhouette Lift, Inc.2020-03-27
K192580STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc.2019-12-18
K183183VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.2019-06-27