Cleared Traditional

K970372 - GASTROSCOPE AND COLONOSCOPE NOZZLE REPL...

K970372 is an FDA 510(k) clearance for GASTROSCOPE AND COLONOSCOPE NOZZLE REPL..., manufactured by Precision Endoscopy of America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K970372 · Precision Endoscopy of America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
39d
Days
Class 2
Risk

K970372 is an FDA 510(k) clearance for the GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Precision Endoscopy of America, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 39 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 Precision Endoscopy of America, Inc. devices

FDA 510(k) Submission Details - K970372

510(k) Number K970372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date March 11, 1997
Days to Decision 39 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
91d faster than avg
Panel avg: 130d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDF Device Classification - Class 2, Special Controls

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum 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 - FDF Colonoscope And Accessories, Flexible/rigid

All 73
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K970372.
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K961570 · Pentax Precision Instrument Corp. · Jun 1996
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K961563 · Pentax Precision Instrument Corp. · Jun 1996
EC-3800L, VIDEO COLONOSCOPE
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