Cleared Traditional

GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED (K914140) - FDA 510(k) Clearance

Class I General Hospital device.

K914140 · Bissell Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
197d
Days
Class 1
Risk

K914140 is an FDA 510(k) clearance for the GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Bissell Medical Products, Inc. (Naperville, US). The FDA issued a Cleared decision on March 31, 1992 after a review of 197 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6900 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bissell Medical Products, Inc. devices

Submission Details

510(k) Number K914140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date March 31, 1992
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPP Stretcher, Hand-carried
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.