Submission Details
| 510(k) Number | K170767 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2017 |
| Decision Date | November 01, 2017 |
| Days to Decision | 232 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Special
Surgical Stainless Steel Suture, Stainless Steel Suture
Nov 2017
Decision
232d
Days
Class 2
Risk
About This 510(k) Submission
K170767 is an FDA 510(k) clearance for the Surgical Stainless Steel Suture, Stainless Steel Suture, a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II — Special Controls, product code GAQ), submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on November 1, 2017, 232 days after receiving the submission on March 14, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4495.
Device Classification
| Product Code | GAQ — Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4495 |
Manufacturer
Similar Devices — GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
All 31
K203855 · Conextions Medical
· Apr 2022
K193209 · Foosin Medical Supplies Inc., Ltd.
· Feb 2020
K172146 · M/s. Meril Endo Surgery Private Limited.
· Feb 2018
K141007 · Demetech Corp.
· Sep 2014
K140127 · Pontis Orthopaedics, LLC
· May 2014
K081060 · Core Essence Orthopaedics, LLC
· Dec 2008
More from Ethicon, Inc.
View all
K253852
· GAM · Feb 2026
K252743
· GAM · Dec 2025
K243897
· NEW · Nov 2025
K221744
· GAM · Nov 2022
K212380
· NEW · Feb 2022