FDA 510(k)

Sofsilk Coated Braided Silk Suture

K-Number: K241486 · 2024-12-03

Decision Date2024-12-03

Product CodeGAP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Sofsilk Coated Braided Silk Suture is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2024-12-03 under approval number K241486. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sofsilk Coated Braided Silk Suture?

Sofsilk Coated Braided Silk Suture is a medical device that received FDA 510(k) clearance on 2024-12-03. It is manufactured by Covidien. The 510(k) number is K241486.

When was Sofsilk Coated Braided Silk Suture approved by the FDA?

Sofsilk Coated Braided Silk Suture received FDA 510(k) clearance on 2024-12-03, under approval number K241486.

What company makes Sofsilk Coated Braided Silk Suture?

Sofsilk Coated Braided Silk Suture is manufactured by Covidien.

What is the FDA product code for Sofsilk Coated Braided Silk Suture?

The FDA product code for Sofsilk Coated Braided Silk Suture is GAP.

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Related Devices (Code: GAP)

K162396SILK Surgical SutureTeleflexmedical, Inc. K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited. K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical SutureM/s. Meril Endo Surgery Private Limited. K180701SafePath Suturing SystemSafepath Medical, Inc. K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd. K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.