Cleared Special

K984444 - INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000

K984444 is an FDA 510(k) clearance for INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, manufactured by Sandhill Scientific, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFX cleared through the Special 510(k) pathway after a 28-day FDA review.

K984444 · Sandhill Scientific, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
28d
Days
Class 2
Risk

K984444 is an FDA 510(k) clearance for the INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Sandhill Scientific, Inc. (Highlands Ranch, US). The FDA issued a Cleared decision on January 11, 1999 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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.

FDA 510(k) Submission Details - K984444

510(k) Number K984444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1998
Decision Date January 11, 1999
Days to Decision 28 days
Submission Type Special
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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FFX Device Classification - Class 2, Special Controls

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 Peers - FFX System, Gastrointestinal Motility (electrical)

All 69
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K984444.
GASTRIC AND RECTAL CATHETERS
K973844 · G & J Electronics, Inc. · Jun 1999
INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
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DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
K981733 · Medtronic Functional Diagnostics A/S · Feb 1999
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50
K980980 · Konigsberg Instruments, Inc. · Jun 1998
MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
K980946 · Dentsleeve Pty., Ltd. · Jun 1998
ANORECTAL MANOMETRY ANALYSIS MODULE
K972439 · Medtronic-Synectics · Sep 1997
K984444 · INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000
Download PDF FDA Summary Sandhill Scientific, …