Cleared Traditional

K944795 - KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES

K944795 is an FDA 510(k) clearance for KARL STORZ UNIPOLAR BALL, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAS cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K944795 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
84d
Days
Class 2
Risk

K944795 is an FDA 510(k) clearance for the KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES. Classified as Electrode, Electrosurgical, Active, Urological (product code FAS), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 21, 1994 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K944795

510(k) Number K944795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1994
Decision Date December 21, 1994
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 131d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAS Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (FAS) and FDA review panel - the closest regulatory comparables to K944795.
POWER RESECTOSCOPE CUTTING LOOP
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ENDOSCOPIC ACCESSORY
K945191 · Un-I-Med, Inc. · May 1995
RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP
K943879 · American Urologicals, Inc. · Feb 1995
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
K931763 · Olympus Corp. · Aug 1994
GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE
K933173 · Greenwald Surgical Co., Inc. · Apr 1994
GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
K933174 · Greenwald Surgical Co., Inc. · Apr 1994
K944795 · KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
Download PDF FDA Summary KARL STORZ Endoscopy-…