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FDA 510(k)

SILK Surgical Suture

K-Number: K162396 · 2016-11-23

ApplicantTeleflexmedical, Inc.
Decision Date2016-11-23
Product CodeGAP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILK Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K162396. 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 SILK Surgical Suture?

SILK Surgical Suture is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K162396.

When did SILK Surgical Suture receive FDA 510(k) clearance?

SILK Surgical Suture received FDA 510(k) clearance on 2016-11-23, under 510(k) number K162396.

Who is the listed applicant for SILK Surgical Suture?

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

What is the FDA product code for SILK Surgical Suture?

The FDA product code for SILK Surgical Suture is GAP.

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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.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.

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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