Cleared Traditional

Gastro Concepts Air Assist (K242668) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242668 · Gastro Concepts, LLC · Gastroenterology & Urology device
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Dec 2024
Decision
99d
Days
Class 2
Risk

K242668 is an FDA 510(k) clearance for the Gastro Concepts Air Assist. Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Gastro Concepts, LLC (Wilmington, US). The FDA issued a Cleared decision on December 13, 2024 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gastro Concepts, LLC devices

Submission Details

510(k) Number K242668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2024
Decision Date December 13, 2024
Days to Decision 99 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 130d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Prime Path Medtech
Sarah Moss

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 7
Devices cleared under the same product code (FER) and FDA review panel - the closest regulatory comparables to K242668.
SleeveLUX 24 Anoscope/Proctoscope (P2001)
K250645 · Haemoband Surgical, Ltd. · Oct 2025
WellCare Anoscope
K230439 · Well Care (Wuhan) Medical Technology Co., Ltd. · Dec 2023
Applied Medical Anoscope
K200021 · Applied Medical Resources · Jan 2021
ETHICON ENDO SURGERY SLOTTED ANOSCOPE
K093896 · Ethicon Endo-Surgery, Inc. · Mar 2010
ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
K881469 · Baxter Healthcare Corp · Sep 1988
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · Welch Allyn, Inc. · Feb 1981