Cleared Traditional

NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000 (K050650) - FDA 510(k) Clearance

Also marketed or referenced as:
NCAM1000

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050650 · Cytyc Surgical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
63d
Days
Class 2
Risk

K050650 is an FDA 510(k) clearance for the NOVACYTE MICROENDOSCOPE AND ACCESSORIES, MODELS NC1000. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Cytyc Surgical Products (Palo Alto, US). The FDA issued a Cleared decision on May 16, 2005 after a review of 63 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.

View all Cytyc Surgical Products devices

Submission Details

510(k) Number K050650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2005
Decision Date May 16, 2005
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050650.
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
K060777 · Smith & Nephew, Inc. · Apr 2006
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
K050209 · Smith & Nephew, Inc. · Nov 2005
ENDOSCOPIC APPLICATOR
K051732 · Ethicon, Inc. · Aug 2005
MODIFIED SPACEMAKER SYSTEM
K042412 · United States Surgical, A Division of Tyco Healthc · Sep 2004
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
K041827 · Boston Scientific Corp · Aug 2004
DAVOL DELIVERY SYSTEM
K041641 · C.R. Bard, Inc. · Jul 2004