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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 the device name listed in this FDA 510(k) record. The listed applicant is Safepath Medical, Inc.. It received FDA 510(k) clearance on 2018-06-25 under 510(k) 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. The listed applicant is Safepath Medical, Inc.. The 510(k) number is K180701.

When did SafePath Suturing System receive FDA 510(k) clearance?

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

Who is the listed applicant for SafePath Suturing System?

The FDA 510(k) record lists Safepath Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafePath Suturing System?

The FDA product code for SafePath Suturing System is GAP.

Other records listing Safepath Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: GAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241486Sofsilk™ Coated Braided Silk SutureCovidienK222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc.K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.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.K162396SILK Surgical SutureTeleflexmedical, 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.

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