Cleared Traditional

K971977 - KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBER...

K971977 is the FDA 510(k) clearance for KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBER... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FBN) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K971977 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
75d
Days
Class 2
Risk

K971977 is an FDA 510(k) clearance for the KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE. Classified as Choledochoscope And Accessories, Flexible/rigid (product code FBN), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on August 12, 1997 after a review of 75 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K971977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date August 12, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 130d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FBN Choledochoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Bile Ducts. 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 - FBN Choledochoscope And Accessories, Flexible/rigid

All 34
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