Cleared Traditional

GASTROTEC (K954401) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K954401 · Patrick C. Jacobssen · Ear, Nose, Throat device
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Apr 1996
Decision
218d
Days
Class 3
Risk

K954401 is an FDA 510(k) clearance for the GASTROTEC. Classified as Polymer, Natural-absorbable Gelatin Material (product code ESI), Class III - Premarket Approval.

Submitted by Patrick C. Jacobssen (Fairhope, US). The FDA issued a Cleared decision on April 25, 1996 after a review of 218 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Patrick C. Jacobssen devices

Submission Details

510(k) Number K954401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1995
Decision Date April 25, 1996
Days to Decision 218 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 89d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESI Polymer, Natural-absorbable Gelatin Material
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.