Cleared Special

K070712 - MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM

K070712 is an FDA 510(k) clearance for MODIFICATION TO: YELLOPORT PORT ACCESS ..., manufactured by Surgical Innovations Group Plc. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Special 510(k) pathway after a 14-day FDA review.

K070712 · Surgical Innovations Group Plc · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
14d
Days
Class 2
Risk

K070712 is an FDA 510(k) clearance for the MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Surgical Innovations Group Plc (Leeds, GB). The FDA issued a Cleared decision on March 28, 2007 after a review of 14 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.

FDA 510(k) Submission Details - K070712

510(k) Number K070712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2007
Decision Date March 28, 2007
Days to Decision 14 days
Submission Type Special
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
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Intertek Testing Services
NEIL E DEVINE

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 1428
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K070712.
VIEW MD OFFICE SYSTEM, MODEL 41066.5540
K071292 · Richard Wolf Medical Instruments Corp. · Jul 2007
REALHAND HIGH DEXTERITY (HD) INSTRUMENTS
K071488 · Novare Surgical Systems, Inc. · Jun 2007
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02
K070198 · Ethicon Endo-Surgery, LLC · Jun 2007
FISSO HOLDING SYSTEM
K070509 · Baitella AG · Mar 2007
SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA
K063859 · Surgiquest, Inc. · Mar 2007
560 HIGH DEFINITION CAMERA SYSTEM
K070266 · Smith & Nephew, Inc. · Feb 2007

FDA 510(k) Resources - General & Plastic Surgery

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

K070712 · MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM
Download PDF FDA Summary Surgical Innovations …