Cleared Traditional

K060629 - GELPORT BLUNT TIP TROCAR SYSTEM

K060629 is an FDA 510(k) clearance for GELPORT BLUNT TIP TROCAR SYSTEM, manufactured by Applied Medical Resources Corp.. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K060629 · Applied Medical Resources Corp. · General & Plastic Surgery device
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Apr 2006
Decision
29d
Days
Class 2
Risk

K060629 is an FDA 510(k) clearance for the GELPORT BLUNT TIP TROCAR SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on April 7, 2006 after a review of 29 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 Applied Medical Resources Corp. devices

FDA 510(k) Submission Details - K060629

510(k) Number K060629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2006
Decision Date April 07, 2006
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

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 803
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K060629.
LAPARO-THORACO VIDEOSCOPE XLTF-VAW
K053382 · Olympus Medical Systems Corporation · May 2006
STRYKER SCOPE/INSTRUMENT HOLDER
K060085 · Stryker Endoscopy · Apr 2006
SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
K060777 · Smith & Nephew, Inc. · Apr 2006
INTUITIVE SURGICAL SEAL
K060534 · Applied Medical Resources Corp. · Mar 2006
STRYKER SCOPE WARMER
K053311 · Stryker Endoscopy · Jan 2006
MODULAR TROCAR SYSTEM
K060096 · Applied Medical Resources Corp. · Jan 2006

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.