Cleared Traditional

K884857 - COLONOSCOPE GUIDING TUBE DEVICE

K884857 is an FDA 510(k) clearance for COLONOSCOPE GUIDING TUBE DEVICE, manufactured by Mill-Rose Laboratory. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K884857 · Mill-Rose Laboratory · Gastroenterology & Urology device
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Mar 1989
Decision
116d
Days
Class 2
Risk

K884857 is an FDA 510(k) clearance for the COLONOSCOPE GUIDING TUBE DEVICE. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 116 days - within the typical 510(k) review window.

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 Mill-Rose Laboratory devices

FDA 510(k) Submission Details - K884857

510(k) Number K884857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1988
Decision Date March 17, 1989
Days to Decision 116 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
15d faster than avg
Panel avg: 131d · This submission: 116d
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 94
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K884857.
FC-38LH, FIBER COLONOSCCOPE
K951580 · Pentax Precision Instrument Corp. · Jun 1995
VISION SYSTEM COLONSCOPE
K943895 · Vision-Sciences, Inc. · Feb 1995
SULLIVAN VARIABLE STIFFNESS CABLE
K901610 · Wilson-Cook Medical, Inc. · Jun 1990
PENTAX FC-38LA & FC-38SA COLONOFIBER
K822846 · Pentax Precision Instrument Corp. · Oct 1982
PENTAX COLONOSCOPE MODEL FC-34LA
K810682 · Pentax Precision Instrument Corp. · Apr 1981
PENTAX COLONOSCOPE MODEL FC-34 MA
K810791 · Pentax Precision Instrument Corp. · Mar 1981