PTFE SURGICAL SUTURE— 510(k) K180630

Substantially Equivalent

Omnia Spa

FDA 510(k) clearance K180630 for PTFE SURGICAL SUTURE, Substantially Equivalent on 2018-04-06. Applicant: Omnia Spa. Device class: 2.

Clearance details

Applicant: Omnia Spa
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2018-03-09
Decision date: 2018-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Fidenza, IT

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 Omnia Spa

K132464 — PTFE SURGICAL SUTURE2014-02-12
K110724 — SURGICAL PROCEDURE PACKS2011-06-23

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