Cleared Traditional

K810682 - PENTAX COLONOSCOPE MODEL FC-34LA

K810682 is the FDA 510(k) clearance for PENTAX COLONOSCOPE MODEL FC-34LA 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 21-day FDA review.

K810682 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
21d
Days
Class 2
Risk

K810682 is an FDA 510(k) clearance for the PENTAX COLONOSCOPE MODEL FC-34LA. 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 April 3, 1981 after a review of 21 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 K810682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1981
Decision Date April 03, 1981
Days to Decision 21 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
109d faster than avg
Panel avg: 130d · This submission: 21d
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 K810682.
SULLIVAN VARIABLE STIFFNESS CABLE
K901610 · Wilson-Cook Medical, Inc. · Jun 1990
COLONOSCOPE GUIDING TUBE DEVICE
K884857 · Mill-Rose Laboratory · Mar 1989
PENTAX FC-38LA & FC-38SA COLONOFIBER
K822846 · Pentax Precision Instrument Corp. · Oct 1982
PENTAX COLONOSCOPE MODEL FC-34 MA
K810791 · Pentax Precision Instrument Corp. · Mar 1981
PENTEX FEXIBLE COLONSCOPE, MOD. FC-34A
K801223 · Pentax Precision Instrument Corp. · Jun 1980
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
K792179 · American Optical Corp. · Dec 1979