Cleared Traditional

K850020 - PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBER...

K850020 is the FDA 510(k) clearance for PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBER... by Pentax Precision Instrument Corp.. It is a Class 2 Gastroenterology & Urology device (product code FDS) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K850020 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
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Jul 1985
Decision
186d
Days
Class 2
Risk

K850020 is an FDA 510(k) clearance for the PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K850020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1985
Decision Date July 09, 1985
Days to Decision 186 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
56d slower than avg
Panel avg: 130d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data 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.

Regulatory Peers - FDS Gastroscope And Accessories, Flexible/rigid

All 62
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K850020.
EG-2940, VIDEO GASTROSCOPE
K961564 · Pentax Precision Instrument Corp. · Jul 1996
VISION SYSTEM UPPER G.I. EXDOSCOPE
K943715 · Vision-Sciences, Inc. · Feb 1995
OLYMPUS MEASURING DEVICES
K933717 · Olympus Corp. · Nov 1993
TWO CHANNEL GASTROFIBERSCOPE FG-36T
K833924 · Pentax Precision Instrument Corp. · Feb 1984
PENTAX FG-34JA GASTROFIBERSCOPE
K832007 · Pentax Precision Instrument Corp. · Aug 1983