Cleared Traditional

WalterLorenz Surgical Assist Arm Scope Holder

K190576 · Biomet Microfixation · General & Plastic Surgery
Jun 2019
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K190576 is an FDA 510(k) clearance for the WalterLorenz Surgical Assist Arm Scope Holder, a Endoscope Holder (Class II — Special Controls, product code OCV), submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on June 5, 2019, 91 days after receiving the submission on March 6, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K190576 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2019
Decision Date June 05, 2019
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OCV — Endoscope Holder
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold Endoscope In A Desired Position During Procedures.