Cleared Traditional

K002231 - LF-DP GASTROINTESTINAL AND SIGMOID FIBE...

K002231 is an FDA 510(k) clearance for LF-DP GASTROINTESTINAL AND SIGMOID FIBE..., manufactured by Olympus Optical Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDS cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K002231 · Olympus Optical Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
190d
Days
Class 2
Risk

K002231 is an FDA 510(k) clearance for the LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUI.... Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Olympus Optical Co., Ltd. (Melville, US). The FDA issued a Cleared decision on January 30, 2001 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Optical Co., Ltd. devices

FDA 510(k) Submission Details - K002231

510(k) Number K002231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date January 30, 2001
Days to Decision 190 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
60d slower than avg
Panel avg: 130d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDS Device Classification - Class 2, Special Controls

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 65
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