Cleared Traditional

K050829 - NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM

K050829 is an FDA 510(k) clearance for NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM, manufactured by Conmed Integrated Systems (Cmis). The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K050829 · Conmed Integrated Systems (Cmis) · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
35d
Days
Class 2
Risk

K050829 is an FDA 510(k) clearance for the NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Conmed Integrated Systems (Cmis) (Beaverton, US). The FDA issued a Cleared decision on May 6, 2005 after a review of 35 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K050829

510(k) Number K050829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2005
Decision Date May 06, 2005
Days to Decision 35 days
Submission Type Traditional
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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1428
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K050829.
HANS HERMANN LAPAROSCOPES AND ACCESSORIES
K051610 · Hans Hermann GmbH · Jul 2005
ARMAND ENDOSCOPE HOLDER
K050051 · KLS-Martin L.P. · May 2005
NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000
K050650 · Cytyc Surgical Products · May 2005
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
K050639 · Lumenis, Inc. · Mar 2005
HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE
K050163 · Henke Sass Wolf of America, Inc. · Mar 2005
ENDOLINK TRUE MOVEMENT SYSTEM
K043541 · Novare Surgical Systems, Inc. · Mar 2005
K050829 · NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
Download PDF FDA Summary Conmed Integrated Sys…