Cleared Abbreviated

K023735 - LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001

K023735 is an FDA 510(k) clearance for LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM A..., manufactured by Medsys, S.A.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Abbreviated 510(k) pathway after a 273-day FDA review.

K023735 · Medsys, S.A. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
273d
Days
Class 2
Risk

K023735 is an FDA 510(k) clearance for the LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Medsys, S.A. (Puyallup, US). The FDA issued a Cleared decision on August 7, 2003 after a review of 273 days - an extended review 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Medsys, S.A. devices

FDA 510(k) Submission Details - K023735

510(k) Number K023735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2002
Decision Date August 07, 2003
Days to Decision 273 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 115d · This submission: 273d
Pathway characteristics
Standards-based clearance path.

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 922
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K023735.
SOPRO 61D
K031593 · Sopro · Sep 2003
ENDOSCOPIC APPLICATOR
K031882 · Baxter Healthcare Corp · Sep 2003
CARDIOVATIONS PORTABLE VIDEO SYSTEM
K032339 · Ethicon, Inc. · Aug 2003
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