Cleared Traditional

K981733 - DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 (FDA 510(k) Clearance)

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

K981733 · Medtronic Functional Diagnostics A/S · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
262d
Days
Class 2
Risk

K981733 is an FDA 510(k) clearance for the DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by Medtronic Functional Diagnostics A/S (Skovlunde, DK). The FDA issued a Cleared decision on February 4, 1999 after a review of 262 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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 Medtronic Functional Diagnostics A/S devices

Submission Details

510(k) Number K981733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date February 04, 1999
Days to Decision 262 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 130d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.