Cleared Special

K093312 - KIMBERLY-CLARK GASTROINTESTINAL ANCHOR ...

K093312 is an FDA 510(k) clearance for KIMBERLY-CLARK GASTROINTESTINAL ANCHOR ..., manufactured by Kimberly-Clark Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KGC cleared through the Special 510(k) pathway after a 47-day FDA review.

K093312 · Kimberly-Clark Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
47d
Days
Class 2
Risk

K093312 is an FDA 510(k) clearance for the KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNA.... Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on December 8, 2009 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology 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.

View all Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K093312

510(k) Number K093312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2009
Decision Date December 08, 2009
Days to Decision 47 days
Submission Type Special
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
83d faster than avg
Panel avg: 130d · This submission: 47d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

KGC Device Classification - Class 2, Special Controls

Product Code KGC Tube, Gastro-enterostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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.
CASEY CONRY

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 - KGC Tube, Gastro-enterostomy

All 15
Devices cleared under the same product code (KGC) and FDA review panel - the closest regulatory comparables to K093312.
PUMA-G System
K183057 · Coaptech, LLC · Apr 2019
Entuit Start Initial Placement Gastrostomy Set
K170323 · Cook Incorporated · Sep 2017
AMT T-FASTENER ANCHOR KIT
K120587 · Applied Medical Technology, Inc. · May 2012
MEDLINE GASTROSTOMY TUBE
K073718 · Medline Industries, Inc. · Mar 2008
KIMBERLY-CLARK INTRODUCER KITS
K080253 · Kimberly-Clark Corp. · Feb 2008
AMT DECOMPRESSION TUBES
K980145 · Applied Medical Technology, Inc. · Apr 1998

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.