Cleared Traditional

K951198 - FE-34TH, FIBER ESOPHAGOSCOPE (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951198 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
75d
Days
Class 2
Risk

K951198 is an FDA 510(k) clearance for the FE-34TH, FIBER ESOPHAGOSCOPE. Classified as Esophagoscope, General & Plastic Surgery (product code GCL), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K951198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1995
Decision Date May 30, 1995
Days to Decision 75 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 130d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCL Esophagoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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.