Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2016-11-23 under approval 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. It is manufactured by Teleflexmedical, Inc.. The 510(k) number is K162396.

When was SILK Surgical Suture approved by the FDA?

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

What company makes SILK Surgical Suture?

SILK Surgical Suture is manufactured by Teleflexmedical, Inc..

What is the FDA product code for SILK Surgical Suture?

The FDA product code for SILK Surgical Suture is GAP.

Related Clinical Trials

NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07574086 Stratafix vs. PDS (Fascial Closure RCT) NOT_YET_RECRUITING NCT05261425 Suture Closure Trial COMPLETED NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT07498361 Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial. RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

Other Devices by Teleflexmedical, Inc.

K161075Arrow Epidural Catheter Kit K153089'cottony' II TAPE, PLEDGETS K153010Hudson RCI AquaPak Sterile Prefilled Nebulizers K153076silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL K153063PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM K161770Rusch Silicone Foley Catheter

View all 19 devices →

Related Devices (Code: GAP)

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. 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

View on FDA Database →

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

↑