WEGO-PTFE— 510(k) K170842

Substantially Equivalent

Foosin Medical Supplies Inc., Ltd.

FDA 510(k) clearance K170842 for WEGO-PTFE, Substantially Equivalent on 2017-07-31. Applicant: Foosin Medical Supplies Inc., Ltd.. Device class: 2.

Clearance details

Applicant: Foosin Medical Supplies Inc., Ltd.
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2017-03-21
Decision date: 2017-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weihai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NBY

K231277 — TissueStat2023-11-09
K192088 — GOLNIT Non-aborbable PTFE Surgical Suture2019-09-04
K180992 — Biotex2019-07-16
K191317 — StitchKit2019-07-12
K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture2018-10-11

More clearances from Foosin Medical Supplies Inc., Ltd.

K201139 — WEGO-PDO Barbed Suture2020-10-20
K193209 — Wego-Stainless Steel2020-02-19
K183001 — WEGO-PGLA RAPID2019-01-28
K183004 — WEGO-PGA RAPID2019-01-28
K142810 — WEGO-PGCL Absorbable Surgical Monofilament Suture2014-11-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.