Cleared Traditional

K964131 - ENDOSCOPE

K964131 is an FDA 510(k) clearance for ENDOSCOPE, manufactured by Akos Biomedical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAM cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K964131 · Akos Biomedical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
255d
Days
Class 2
Risk

K964131 is an FDA 510(k) clearance for the ENDOSCOPE. Classified as Sigmoidoscope And Accessories, Flexible/rigid (product code FAM), Class II - Special Controls.

Submitted by Akos Biomedical, Inc. (San Diego, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 255 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 Akos Biomedical, Inc. devices

FDA 510(k) Submission Details - K964131

510(k) Number K964131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date June 27, 1997
Days to Decision 255 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
125d slower than avg
Panel avg: 130d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAM Device Classification - Class 2, Special Controls

Product Code FAM Sigmoidoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Sigmoid (descending) Colon
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 - FAM Sigmoidoscope And Accessories, Flexible/rigid

All 20
Devices cleared under the same product code (FAM) and FDA review panel - the closest regulatory comparables to K964131.
VS-100 VIDEO SIGMOIDOSCOPE
K970382 · Welch Allyn, Inc. · Apr 1997
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
K964326 · Vision-Sciences, Inc. · Jan 1997
VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100
K964100 · Vision-Sciences, Inc. · Dec 1996
DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
K963344 · Vision-Sciences, Inc. · Nov 1996
ES-3840, VIDEO SIGMOIDOSCOPE
K961567 · Pentax Precision Instrument Corp. · Jun 1996
ES-3800, VIDEO SIGMOIDOSCOPE
K951577 · Pentax Precision Instrument Corp. · Mar 1996