Cleared Traditional

K102179 - ENVIEW (TM)

K102179 is an FDA 510(k) clearance for ENVIEW (TM), manufactured by Carefusion 2200. The device is a Class 2 Gastroenterology & Urology device with product code OCV cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K102179 · Carefusion 2200 · Gastroenterology & Urology device
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Dec 2010
Decision
121d
Days
Class 2
Risk

K102179 is an FDA 510(k) clearance for the ENVIEW (TM). Classified as Endoscope Holder (product code OCV), Class II - Special Controls.

Submitted by Carefusion 2200 (San Diego, US). The FDA issued a Cleared decision on December 2, 2010 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carefusion 2200 devices

FDA 510(k) Submission Details - K102179

510(k) Number K102179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2010
Decision Date December 02, 2010
Days to Decision 121 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 130d · This submission: 121d
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 Gastroenterology & Urology 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 K102179.
KARL STORZ Holders
K240506 · KARL STORZ Endoscopy-America, Inc. · Oct 2024
ENDOFIX EXO
K232405 · Aktormed GmbH · Apr 2024
WalterLorenz Surgical Assist Arm Scope Holder
K190576 · Biomet Microfixation · Jun 2019
KSEA ENDOSCOPE HOLDER
K990334 · KARL STORZ Endoscopy-America, Inc. · Mar 1999
SH-1 SURGICAL HOLDER FOR TELESCOPE
K960068 · Olympus America, Inc. · May 1997