Mani Needle & Suture Pack (Silk)

FDA 510(k) K053638 · Mani, Inc.

Substantially Equivalent

510(k) numberK053638

Submission

Device name
Mani Needle & Suture Pack (Silk)
Applicant
Mani, Inc.
Washington, DC, US
Received
December 29, 2005
Decision date
May 19, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GAP – Suture, Nonabsorbable, Silk
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5030
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code GAP

510(k)DeviceApplicantDecision
K241486Sofsilk™ Coated Braided Silk SutureGAP · Traditional Covidien12/03/2024SE
K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…GAP · Traditional Safepath Medical, Inc.10/18/2024SE
K232355Non absorbable Surgical Silk SutureGAP · Traditional Shandong Haidike Medical Product Co., Ltd.01/16/2024SE
K221767Surgical Sutures with or without NeedleGAP · Traditional Huaian Seamen Medical Technology Co., Ltd.07/31/2023SE
K180701SafePath Suturing SystemGAP · Traditional Safepath Medical, Inc.06/25/2018SE
K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Special M/s. Meril Endo Surgery Private Limited.10/20/2017SE
K162396SILK Surgical SutureGAP · Traditional Teleflexmedical, Inc.11/23/2016SE
K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…GAP · Traditional M/s. Meril Endo Surgery Private Limited.05/31/2016SE
K080684Wg-Surgical Sutures with NeedleGAP · Traditional Foosin Medical Supplies, Inc.06/09/2008SE
K071111Non-Absorbable Silk SutureGAP · Traditional Arrow Intl., Inc.07/17/2007SE

More from Arrow Intl., Inc.

510(k)DeviceDecision
K053637Mani Needle & Suture Pack (Nylon)GAR · Traditional 05/19/2006SE
K053636Mani Needle & Suture Pack (Pga Absorbable)GAM · Traditional 03/14/2006SE
K050150Mani Needle & Suture PackGAT · Traditional 12/05/2005SE

Questions and answers

When was Mani Needle & Suture Pack (Silk) cleared by the FDA?

Mani Needle & Suture Pack (Silk) (K053638) received a 510(k) decision of Substantially Equivalent on May 19, 2006, 141 days after the submission was received.

What is the product code of K053638?

The FDA product code is GAP – Suture, Nonabsorbable, Silk, a Class II (moderate risk) device regulated under 21 CFR 878.5030.