Cleared Traditional

K891187 - TECNOL NASO-GASTRIC TUBE HOLDER

K891187 is an FDA 510(k) clearance for TECNOL NASO-GASTRIC TUBE HOLDER, manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code BSS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K891187 · Tecnol New Jersey Wound Care, Inc. · Gastroenterology & Urology device
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May 1989
Decision
85d
Days
Class 2
Risk

K891187 is an FDA 510(k) clearance for the TECNOL NASO-GASTRIC TUBE HOLDER. Classified as Tube, Nasogastric (product code BSS), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on May 30, 1989 after a review of 85 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 Tecnol New Jersey Wound Care, Inc. devices

FDA 510(k) Submission Details - K891187

510(k) Number K891187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date May 30, 1989
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSS Device Classification - Class 2, Special Controls

Product Code BSS Tube, Nasogastric
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.