Cleared Traditional

K961564 - EG-2940

K961564 is the FDA 510(k) clearance for EG-2940 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 77-day FDA review.

K961564 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
77d
Days
Class 2
Risk

K961564 is an FDA 510(k) clearance for the EG-2940, VIDEO GASTROSCOPE. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Miramar, US). The FDA issued a Cleared decision on July 9, 1996 after a review of 77 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 K961564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1996
Decision Date July 09, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
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 K961564.
ULTRASOUND GASTROSCOPE GF TYPE UM30P
K963023 · Olympus America, Inc. · Feb 1997
EG-3400, VIDEO GASTROSCOPE
K962897 · Pentax Precision Instrument Corp. · Oct 1996
EG-3800T, VIDEO GASTROSCOPE
K962460 · Pentax Precision Instrument Corp. · Sep 1996
VISION SYSTEM UPPER G.I. EXDOSCOPE
K943715 · Vision-Sciences, Inc. · Feb 1995
OLYMPUS MEASURING DEVICES
K933717 · Olympus Corp. · Nov 1993
PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23
K850020 · Pentax Precision Instrument Corp. · Jul 1985