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FDA 510(k)

SafePath Suturing System

K-Number: K180701 · 2018-06-25

ApplicantSafepath Medical, Inc.
Decision Date2018-06-25
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SafePath Suturing System is a medical device manufactured by Safepath Medical, Inc.. It received FDA 510(k) clearance on 2018-06-25 under approval number K180701. 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 SafePath Suturing System?

SafePath Suturing System is a medical device that received FDA 510(k) clearance on 2018-06-25. It is manufactured by Safepath Medical, Inc.. The 510(k) number is K180701.

When was SafePath Suturing System approved by the FDA?

SafePath Suturing System received FDA 510(k) clearance on 2018-06-25, under approval number K180701.

What company makes SafePath Suturing System?

SafePath Suturing System is manufactured by Safepath Medical, Inc..

What is the FDA product code for SafePath Suturing System?

The FDA product code for SafePath Suturing System is GAP.

Other Devices by Safepath Medical, Inc.

K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture

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. K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd. K241486Sofsilk™ Coated Braided Silk SutureCovidien K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.

Official Source

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

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