Cleared Traditional

K073009 - ONEPORT SURGICAL TROCAR SYSTEM

K073009 is the FDA 510(k) clearance for ONEPORT SURGICAL TROCAR SYSTEM by Conmed Corporation. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K073009 · Conmed Corporation · General & Plastic Surgery device
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Dec 2007
Decision
43d
Days
Class 2
Risk

K073009 is an FDA 510(k) clearance for the ONEPORT SURGICAL TROCAR SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 43 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 Conmed Corporation devices

Submission Details

510(k) Number K073009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2007
Decision Date December 07, 2007
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
JAY Y KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 671
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K073009.
3 CCD ENDOCAM 5550
K080977 · Richard Wolf Medical Instruments Corp. · May 2008
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MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
K080155 · Intuitive Surgical, Inc. · Mar 2008
KII TROCAR SYSTEM
K072674 · Applied Medical Resources Corp. · Oct 2007
VIEW MD OFFICE SYSTEM, MODEL 41066.5540
K071292 · Richard Wolf Medical Instruments Corp. · Jul 2007
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02
K070198 · Ethicon Endo-Surgery, LLC · Jun 2007

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.