Cleared Traditional

K914140 - GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED

K914140 is an FDA 510(k) clearance for GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/..., manufactured by Bissell Medical Products, Inc.. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 197-day FDA review.

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

FDA 510(k) Submission Details - K914140

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.

FPP Device Classification - Class 1, General Controls

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.