Cleared Traditional

K832007 - PENTAX FG-34JA GASTROFIBERSCOPE

K832007 is the FDA 510(k) clearance for PENTAX FG-34JA GASTROFIBERSCOPE 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 49-day FDA review.

K832007 · Pentax Precision Instrument Corp. · Gastroenterology & Urology device
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Aug 1983
Decision
49d
Days
Class 2
Risk

K832007 is an FDA 510(k) clearance for the PENTAX FG-34JA GASTROFIBERSCOPE. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983 after a review of 49 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 K832007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1983
Decision Date August 11, 1983
Days to Decision 49 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
81d faster than avg
Panel avg: 130d · This submission: 49d
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.