Cleared Special

MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (K003222) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003222 · Computer Motion, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
18d
Days
Class 2
Risk

K003222 is an FDA 510(k) clearance for the MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER. Classified as Laryngoscope, Endoscope (product code GCI), Class II - Special Controls.

Submitted by Computer Motion, Inc. (Goleta, US). The FDA issued a Cleared decision on November 3, 2000 after a review of 18 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Computer Motion, Inc. devices

Submission Details

510(k) Number K003222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2000
Decision Date November 03, 2000
Days to Decision 18 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GCI Laryngoscope, Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.