Sutralene Polypropylene Sutures

FDA 510(k) K070243 · Visionary Medical Supplies, Inc.

Substantially Equivalent

510(k) numberK070243

Submission

Device name
Sutralene Polypropylene Sutures
Applicant
Visionary Medical Supplies, Inc.
Stoughton, WI, US
Received
January 25, 2007
Decision date
April 17, 2007
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5010
Specialty
General, Plastic Surgery
Implant
Yes

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K230746Non absorbable Surgical Polypropylene SutureGAW · Traditional Shandong Haidike Medical Products Co., Ltd.09/14/2023SE
K221280VessealGAW · Traditional Lydus Medical , Ltd.12/09/2022SE
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K192953APTOS Threads – Polypropylene Surgical SuturesGAW · Traditional Aptos, LLC08/27/2020SE
K193530Deklene MAXXGAW · Special Teleflex Medical03/19/2020SE
K191299Silhouette Featherlift / Silhouette LiftGAW · Special Silhouette Lift, Inc.06/14/2019SE
K173747RexleneGAW · Traditional Sm Eng Co., Ltd.12/21/2018SE
K180321Aesculap Optilene Nonabsorbable SutureGAW · Special Aesculap, Inc.03/07/2018SE

More from Aesculap, Inc.

510(k)DeviceDecision
K102592SutrazorbGAM · Abbreviated 02/03/2011SE
K994177Sutrasilk Silk SutureGAP · Traditional 02/08/2000SE
K994176Sutralon Nylon SuturesGAR · Traditional 02/08/2000SE

Questions and answers

When was Sutralene Polypropylene Sutures cleared by the FDA?

Sutralene Polypropylene Sutures (K070243) received a 510(k) decision of Substantially Equivalent on April 17, 2007, 82 days after the submission was received.

What is the product code of K070243?

The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.