WalterLorenz Surgical Assist Arm Scope Holder— 510(k) K190576

Name: FDA 510(k) clearance K190576
Creator: U.S. Food and Drug Administration
Published: 2019-06-05

Substantially Equivalent

Biomet Microfixation

FDA 510(k) clearance K190576 for WalterLorenz Surgical Assist Arm Scope Holder, Substantially Equivalent on 2019-06-05. Applicant: Biomet Microfixation. Device class: 2.

Clearance details

Applicant: Biomet Microfixation
Product code: Code OCV
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-06
Decision date: 2019-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OCV

view all

K240506 — KARL STORZ Holders2024-10-22
K232405 — ENDOFIX EXO2024-04-25
K102179 — ENVIEW (TM)2010-12-02
K093616 — V. MUELLER CAMERA CONTROLLER WITH STORAGE CART2009-12-23
K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-331999-08-17

More clearances from Biomet Microfixation

view all

K261002 — Pectus Blu System2026-06-02
K241709 — Pectus Blu Support Bar System2024-09-19
K223199 — 2.1 x 255mm Drill, 22mm Stop2022-11-15
K212782 — SternaLock Sternal Closure System2022-05-17
K212608 — RibFix Blu Thoracic Fixation System2022-04-22

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