Cleared Traditional

K897181 - L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROST...

K897181 is an FDA 510(k) clearance for L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROST..., manufactured by Intl. Medical Marketing, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K897181 · Intl. Medical Marketing, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
89d
Days
Class 2
Risk

K897181 is an FDA 510(k) clearance for the L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Intl. Medical Marketing, Inc. (Ridge, US). The FDA issued a Cleared decision on March 27, 1990 after a review of 89 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. 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 Intl. Medical Marketing, Inc. devices

FDA 510(k) Submission Details - K897181

510(k) Number K897181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received December 28, 1989
Decision Date March 27, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPD Device Classification - Class 2, Special Controls

Product Code FPD Tube, Feeding
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 Peers - FPD Tube, Feeding

All 20
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K897181.
STOMA MEASURING DEVICE
K914482 · Biosearch Medical Products, Inc. · Dec 1991
FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
K912972 · Abbott Laboratories · Sep 1991
WILSON-COOK PULL THROUGH PEG KIT
K901163 · Wilson-Cook Medical, Inc. · Nov 1990
INFANT FEEDING TUBE
K896559 · Westmark, Sterile Packing Systems, Inc. (Sps) · Mar 1990
KENDALL CURITY FEEDING TUBES
K892431 · The Kendal Co. · May 1989
ENTERAL FEEDING TUBE
K890116 · Hdc Corp. · Apr 1989