Cleared Traditional

K120289 - PEERSCOPE SYSTEM

K120289 is an FDA 510(k) clearance for PEERSCOPE SYSTEM, manufactured by Peermedical. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K120289 · Peermedical · Gastroenterology & Urology device
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Sep 2012
Decision
241d
Days
Class 2
Risk

K120289 is an FDA 510(k) clearance for the PEERSCOPE SYSTEM. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Peermedical (Haifa, IL). The FDA issued a Cleared decision on September 28, 2012 after a review of 241 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 Peermedical devices

FDA 510(k) Submission Details - K120289

510(k) Number K120289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date September 28, 2012
Days to Decision 241 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
111d slower than avg
Panel avg: 130d · This submission: 241d
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 K120289.
FUSE 1C COLONOSCOPY SYSTEM
K132839 · Endochoice, Inc. · Feb 2014
FUJIFILM 600 SERIES ENDOSCOPES
K132210 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2014
EVIS EXERA III VIDEO SYSTEM
K131780 · Olympus Medical Systems Corp. · Aug 2013
FUJINON COLONOSCOPES
K112391 · Fujinon, Inc. · Jul 2012
V1 SYSTEM
K111756 · Olympus Medical Systems Corp. · Mar 2012
EVIS EXERA III VIDEO SYSTEM
K112680 · Olympus Medical Systems Corporation · Feb 2012