Cleared Special

K031720 - MODIFICATION TO HERMES O.R. CONTROL CENTER

K031720 is an FDA 510(k) clearance for MODIFICATION TO HERMES O.R. CONTROL CENTER, 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.

K031720 · Computer Motion, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
38d
Days
Class 2
Risk

K031720 is an FDA 510(k) clearance for the MODIFICATION TO HERMES O.R. 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 July 11, 2003 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 - K031720

510(k) Number K031720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2003
Decision Date July 11, 2003
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 797
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K031720.
VIRTUOSAPH
K031891 · Terumo Cardiovascular Systems Corp. · Jul 2003
CARDIOVATIONS RETRACTOR
K031847 · Ethicon, Inc. · Jul 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031956 · Computer Motion, Inc. · Jul 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031382 · Computer Motion, Inc. · Jun 2003
MERDOC SYSTEM
K022393 · Stryker Endoscopy · Jun 2003
SCB COMPUTER MOTION INTERFACE CONTROLLER
K030718 · Computer Motion, Inc. · Jun 2003