Cleared Traditional

SERRALSILK

K020901 · Serral, S.A. DE C.V. · General & Plastic Surgery
Apr 2002
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K020901 is an FDA 510(k) clearance for the SERRALSILK, a Suture, Nonabsorbable, Silk (Class II — Special Controls, product code GAP), submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on April 26, 2002, 37 days after receiving the submission on March 20, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5030.

Submission Details

510(k) Number K020901 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2002
Decision Date April 26, 2002
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GAP — Suture, Nonabsorbable, Silk
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5030

Similar Devices — GAP Suture, Nonabsorbable, Silk

All 40
Sofsilk? Coated Braided Silk Suture
K241486 · Covidien · Dec 2024
SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
K222944 · Safepath Medical, Inc. · Oct 2024
Non absorbable Surgical Silk Suture
K232355 · Shandong Haidike Medical Product Co., Ltd. · Jan 2024
Surgical Sutures with or without Needle
K221767 · Huaian Seamen Medical Technology Co., Ltd. · Jul 2023
SafePath Suturing System
K180701 · Safepath Medical, Inc. · Jun 2018
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
K172149 · M/s. Meril Endo Surgery Private Limited. · Oct 2017