Cleared Traditional

K801223 - PENTEX FEXIBLE COLONSCOPE

K801223 is the FDA 510(k) clearance for PENTEX FEXIBLE COLONSCOPE by Pentax Precision Instrument Corp.. It is a Class 2 Gastroenterology & Urology device (product code FDF) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K801223 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
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Jun 1980
Decision
17d
Days
Class 2
Risk

K801223 is an FDA 510(k) clearance for the PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 17 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 K801223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1980
Decision Date June 09, 1980
Days to Decision 17 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
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K801223.
PENTAX FC-38LA & FC-38SA COLONOFIBER
K822846 · Pentax Precision Instrument Corp. · Oct 1982
PENTAX COLONOSCOPE MODEL FC-34LA
K810682 · Pentax Precision Instrument Corp. · Apr 1981
PENTAX COLONOSCOPE MODEL FC-34 MA
K810791 · Pentax Precision Instrument Corp. · Mar 1981
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
K792179 · American Optical Corp. · Dec 1979
COLONOSCOPE, MODEL SC-4 FLEXIBLE FIBER
K790338 · American Optical Corp. · Apr 1979