STITCHKIT— 510(k) K123811

Substantially Equivalent

Origami Surgical, LLC

FDA 510(k) clearance K123811 for STITCHKIT, Substantially Equivalent on 2013-09-05. Applicant: Origami Surgical, LLC. Device class: 2.

Clearance details

Applicant: Origami Surgical, LLC
Product code: Code NBY
Device class: Class 2
Regulation: 21 CFR 878.5035
Advisory panel: General, Plastic Surgery
Date received: 2012-12-11
Decision date: 2013-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, MA, US

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 Origami Surgical, LLC

K173874 — StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO2018-05-04
K142639 — StitchKit2014-12-16

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