Cleared Traditional

K190576 - WalterLorenz Surgical Assist Arm Scope Holder

K190576 is an FDA 510(k) clearance for WalterLorenz Surgical Assist Arm Scope ..., manufactured by Biomet Microfixation. The device is a Class 2 General & Plastic Surgery device with product code OCV cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

K190576 is an FDA 510(k) clearance for the WalterLorenz Surgical Assist Arm Scope Holder. Classified as Endoscope Holder (product code OCV), Class II - Special Controls.

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on June 5, 2019 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Microfixation devices

FDA 510(k) Submission Details - K190576

510(k) Number K190576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCV Device Classification - Class 2, Special Controls

Product Code OCV Endoscope Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Hold Endoscope In A Desired Position During Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OCV Endoscope Holder

Devices cleared under the same product code (OCV) and FDA review panel - the closest regulatory comparables to K190576.
KARL STORZ Holders
K240506 · KARL STORZ Endoscopy-America, Inc. · Oct 2024
ENDOFIX EXO
K232405 · Aktormed GmbH · Apr 2024
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
K992006 · Integra Neurocare, LLC · Aug 1999
KSEA ENDOSCOPE HOLDER
K990334 · KARL STORZ Endoscopy-America, Inc. · Mar 1999
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
K971584 · Clarus Medical Systems, Inc. · May 1997
SH-1 SURGICAL HOLDER FOR TELESCOPE
K960068 · Olympus America, Inc. · May 1997