Cleared Special

K022897 - MODIFICATION TO HERMES OPERATING ROOM C...

K022897 is an FDA 510(k) clearance for MODIFICATION TO HERMES OPERATING ROOM C..., manufactured by Computer Motion, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 38-day FDA review.

K022897 · Computer Motion, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
38d
Days
Class 2
Risk

K022897 is an FDA 510(k) clearance for the MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Computer Motion, Inc. (Goleta, US). The FDA issued a Cleared decision on October 11, 2002 after a review of 38 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

FDA 510(k) Submission Details - K022897

510(k) Number K022897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date October 11, 2002
Days to Decision 38 days
Submission Type Special
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
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

GCJ Device Classification - Class 2, Special Controls

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GCJ Laparoscope, General & Plastic Surgery

All 798
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K022897.
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K024294 · Computer Motion, Inc. · Jan 2003
HERMES OPERATING ROOM CONTROL CENTER
K023095 · Computer Motion, Inc. · Nov 2002
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K023053 · Smith & Nephew, Inc. · Oct 2002
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K020915 · Sopro · Jun 2002
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM
K013551 · Computer Motion, Inc. · Mar 2002