FDA 510(k)

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

K-Nummer: K222944 · 2024-10-18

Entscheidungsdatum2024-10-18

ProduktcodeGAP

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture 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 2024-10-18 under 510(k) number K222944. The device is classified under product code GAP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture?

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Safepath Medical, Inc.. The 510(k) number is K222944.

When did SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture receive FDA 510(k) clearance?

SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture received FDA 510(k) clearance on 2024-10-18, under 510(k) number K222944.

Who is the listed applicant for SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture?

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

The FDA product code for SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture is GAP.

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Weitere Einträge mit Safepath Medical, Inc. als Antragsteller

K180701SafePath Suturing System

Verwandte Geräte (Code: GAP)

K241486Sofsilk™ Coated Braided Silk SutureCovidien K232355Nicht resorbierbares Chirurgisches Seide NahtmaterialShandong Haidike Medical Product Co., Ltd.K221767Surgical Sutures with or without NeedleHuaian Seamen Medical Technology Co., Ltd.K180701SafePath Suturing SystemSafepath Medical, Inc.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.

Offizielle Quelle

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