Cleared Traditional

K893888 - HOLLISTER FEEDING TUBE ATTACHMENT DEVICE

K893888 is an FDA 510(k) clearance for HOLLISTER FEEDING TUBE ATTACHMENT DEVICE, manufactured by Hollister, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K893888 · Hollister, Inc. · Gastroenterology & Urology device
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Oct 1989
Decision
140d
Days
Class 2
Risk

K893888 is an FDA 510(k) clearance for the HOLLISTER FEEDING TUBE ATTACHMENT DEVICE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on October 17, 1989 after a review of 140 days - within the typical 510(k) review window.

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: 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K893888

510(k) Number K893888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1989
Decision Date October 17, 1989
Days to Decision 140 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 131d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K893888.
GASTRIC SUMP TUBE
K896210 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990
VINYL BAG W/PUMP ADMINISTRATION SET
K893540 · Sandoz Nutrition · Oct 1989
VINYL BAG W/GRAVITY ADMINISTRATION SET
K893541 · Sandoz Nutrition · Oct 1989
PEDI-TUBE(R) STYLET
K894857 · Biosearch Medical Products, Inc. · Oct 1989
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K885220 · Ethox Corp. · Sep 1989
ENTERA-FLO SPIKE SET
K893209 · Delmed, Inc. · Jul 1989