Cleared Traditional

K945191 - ENDOSCOPIC ACCESSORY

K945191 is the FDA 510(k) clearance for ENDOSCOPIC ACCESSORY by Un-I-Med, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAS) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K945191 · Un-I-Med, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
191d
Days
Class 2
Risk

K945191 is an FDA 510(k) clearance for the ENDOSCOPIC ACCESSORY. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by Un-I-Med, Inc. (Largo, US). The FDA issued a Cleared decision on May 3, 1995 after a review of 191 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - 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 Un-I-Med, Inc. devices

Submission Details

510(k) Number K945191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1994
Decision Date May 03, 1995
Days to Decision 191 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
61d slower than avg
Panel avg: 130d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAS Electrode, Electrosurgical, Active, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 - FAS Electrode, Electrosurgical, Active, Urological

All 19
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K945191.
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
K961069 · Arthrocare Corp. · May 1996
ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
K955531 · Arthrocare Corp. · Feb 1996
ROLLER ELECTRODE
K951863 · Olympus America, Inc. · Aug 1995
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
K944795 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
K931763 · Olympus Corp. · Aug 1994