Cleared Special

K991635 - MODIFICATION TO HERMES OPERATING ROOM C...

K991635 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 15-day FDA review.

K991635 · Computer Motion, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
15d
Days
Class 2
Risk

K991635 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 May 27, 1999 after a review of 15 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 - K991635

510(k) Number K991635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1999
Decision Date May 27, 1999
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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 K991635.
DCI ENDOSCOPE
K991171 · Karl Storz Endoscopy · Jun 1999
DCI ENDOSCOPE
K991228 · Karl Storz Endoscopy · Jun 1999
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
K991734 · Computer Motion, Inc. · Jun 1999
STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
K991703 · Stryker Instruments · May 1999
SMITH & NEPHEW HANDPORT SYSTEM
K990414 · Smith & Nephew, Inc. · Apr 1999
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K990028 · Ethicon Endo-Surgery, Inc. · Apr 1999