Cleared Traditional

K032688 - COLONOSIGHT MODEL 510B

K032688 is an FDA 510(k) clearance for COLONOSIGHT MODEL 510B, manufactured by Sightline Technologies , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K032688 · Sightline Technologies , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
189d
Days
Class 2
Risk

K032688 is an FDA 510(k) clearance for the COLONOSIGHT MODEL 510B. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Sightline Technologies , Ltd. (Haifa, IL). The FDA issued a Cleared decision on March 5, 2004 after a review of 189 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 Sightline Technologies , Ltd. devices

FDA 510(k) Submission Details - K032688

510(k) Number K032688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2003
Decision Date March 05, 2004
Days to Decision 189 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
59d slower than avg
Panel avg: 130d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDF Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K032688.
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
K063585 · KARL STORZ Endoscopy-America, Inc. · Jan 2007
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
K051541 · Olympus America, Inc. · Jul 2005
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
K041903 · Fujinon, Inc. · Nov 2004
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
K961570 · Pentax Precision Instrument Corp. · Jun 1996
EC-384OTL, VIDEO COLONSCOPE
K961563 · Pentax Precision Instrument Corp. · Jun 1996
EC-3800L, VIDEO COLONOSCOPE
K951574 · Pentax Precision Instrument Corp. · Mar 1996