Cleared Special

Pure Vu System (K210981) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210981 · Motus GI Medical Technologies , Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Apr 2021
Decision
28d
Days
Class 2
Risk

K210981 is an FDA 510(k) clearance for the Pure Vu System. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Motus GI Medical Technologies , Ltd. (Tirat Carmel, IL). The FDA issued a Cleared decision on April 29, 2021 after a review of 28 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 Motus GI Medical Technologies , Ltd. devices

Submission Details

510(k) Number K210981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2021
Decision Date April 29, 2021
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 41
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K210981.
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
K210052 · Saneso, Inc. · Apr 2022
Pure-Vu EVS System
K220007 · Motus GI Medical Technologies , Ltd. · Feb 2022
DiLumen C2 and Tool Mount
K211819 · Lumendi, LLC · Oct 2021
DiLumen Endolumenal Interventional Platform (DiLumen)
K210851 · Lumendi, LLC · Apr 2021
G-EYE System
K202469 · Smart Medical Systems , Ltd. · Oct 2020
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
K192793 · Olympus Medical Systems Corp. · Jul 2020