Cleared Traditional

Su2ura Approximation Device

K201744 · Anchora Medical, Ltd. · General & Plastic Surgery

Jun 2021

Decision

357d

Days

Class 2

Risk

About This 510(k) Submission

K201744 is an FDA 510(k) clearance for the Su2ura Approximation Device, a Endoscopic Tissue Approximation Device (Class II — Special Controls, product code OCW), submitted by Anchora Medical, Ltd. (I.Z. Yokneam, IL). The FDA issued a Cleared decision on June 17, 2021, 357 days after receiving the submission on June 25, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K201744 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2020
Decision Date	June 17, 2021
Days to Decision	357 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OCW — Endoscopic Tissue Approximation Device
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.