Cleared Traditional

K862107 - PENN & OLYMPUS URETEROSCOPY GUIDE SHEAT...

K862107 is an FDA 510(k) clearance for PENN & OLYMPUS URETEROSCOPY GUIDE SHEAT..., manufactured by Penn Medical Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K862107 · Penn Medical Devices, Inc. · Gastroenterology & Urology device
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Sep 1986
Decision
100d
Days
Class 2
Risk

K862107 is an FDA 510(k) clearance for the PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Penn Medical Devices, Inc. (Basking Ridge, US). The FDA issued a Cleared decision on September 11, 1986 after a review of 100 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 Penn Medical Devices, Inc. devices

FDA 510(k) Submission Details - K862107

510(k) Number K862107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date September 11, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 130d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODC Device Classification - Class 2, Special Controls

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 51
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K862107.
CONCENTRIC BALLOON GOOGLE
K112698 · United States Endoscopy Group, Inc. · May 2012
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431
K073484 · Ethicon Endo-Surgery, Inc. · Mar 2008
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · Boston Scientific Corp · Mar 2001