Cleared Special

HERMES PORT EXPANDER (K003217) - FDA 510(k) Clearance

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

K003217 · Computer Motion, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
21d
Days
Class 2
Risk

K003217 is an FDA 510(k) clearance for the HERMES PORT EXPANDER. 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 November 3, 2000 after a review of 21 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 K003217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2000
Decision Date November 03, 2000
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 354
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K003217.
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K010346 · KARL STORZ Endoscopy-America, Inc. · May 2001
DYONICS VISION 111 MOBILE VIDEO UNIT
K010489 · Smith & Nephew, Inc. · Apr 2001
3D ENDOSCOPE
K002924 · KARL STORZ Endoscopy-America, Inc. · Nov 2000
MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K001666 · Intuitive Surgical, Inc. · Aug 2000
KSEA MANHES PNEUMOTROCAR
K000769 · KARL STORZ Endoscopy-America, Inc. · Jun 2000
SMITH & NEPHEW HANDPORT SYSTEM
K990414 · Smith & Nephew, Inc. · Apr 1999