Cleared Traditional

K110792 - GELPOINT PATH

K110792 is an FDA 510(k) clearance for GELPOINT PATH, manufactured by Applied Medical Resources Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FER cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K110792 · Applied Medical Resources Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
63d
Days
Class 2
Risk

K110792 is an FDA 510(k) clearance for the GELPOINT PATH. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on May 23, 2011 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 - K110792

510(k) Number K110792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2011
Decision Date May 23, 2011
Days to Decision 63 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
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
68d faster than avg
Panel avg: 131d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FER Device Classification - Class 2, Special Controls

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
JEFF D RONGERO

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 - FER Anoscope And Accessories

All 23
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K110792.
THD N-ANO ANOSCOPE
K133687 · Thd Spa · Dec 2013
ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
K121604 · Obp Corporation · Jul 2012
THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
K121135 · Thd Spa · Jun 2012
THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
K103647 · Thd Spa · Mar 2011
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
K091490 · Thd Spa · Jun 2009

FDA 510(k) Resources - Gastroenterology & Urology

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