Cleared Special

K221174 - Telepack +

K221174 is the FDA 510(k) clearance for Telepack + by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FET) cleared through the Special 510(k) pathway after a 18-day FDA review.

K221174 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
18d
Days
Class 2
Risk

K221174 is an FDA 510(k) clearance for the Telepack +. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on May 13, 2022 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K221174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date May 13, 2022
Days to Decision 18 days
Submission Type Special
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
112d faster than avg
Panel avg: 130d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

All 52
Devices cleared under the same product code (FET) and FDA review panel - the closest regulatory comparables to K221174.
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
K241371 · Olympus Medical Systems Corporation · Jul 2024
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
K222584 · Olympus Medical Systems Corporation · Apr 2023
Logic Hd camera head green, System green
K212808 · Richard Wolf Medical Instruments Corporation · Jun 2022
D Camera Controller
K211332 · Richard Wolf Medical Instruments Corporation · Oct 2021
Visera Elite II Video System Center
K202646 · Olympus Medical Systems Corp. · Oct 2020
Image1 S CCU, Image1 S 4U Camera Head
K201135 · KARL STORZ Endoscopy-America, Inc. · Sep 2020