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510(k) K183183

Device
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
Applicant
Ethicon, Inc.
510(k) number
K183183
Product code
GAM  
Decision
Substantially Equivalent (SESE)
Decision date
2019-06-27
Date received
2018-11-19
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

Applicant Contact#

Contact
Stephanie Saati
Address
Rte. 22 W. P.O. Box 151 Somerville NJ US 08876 08876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronic2026-05-28
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
K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.2022-11-15
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

Legacy Summary#

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FDA Review#

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