FDA 510(k)

Darwin

K-Number: K212607 · 2021-11-15

ApplicantLuvo Medical Technologies, Inc.

Decision Date2021-11-15

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Darwin is a medical device manufactured by Luvo Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-11-15 under approval number K212607. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Darwin?

Darwin is a medical device that received FDA 510(k) clearance on 2021-11-15. It is manufactured by Luvo Medical Technologies, Inc.. The 510(k) number is K212607.

When was Darwin approved by the FDA?

Darwin received FDA 510(k) clearance on 2021-11-15, under approval number K212607.

What company makes Darwin?

Darwin is manufactured by Luvo Medical Technologies, Inc..

What is the FDA product code for Darwin?

The FDA product code for Darwin is GEX. This falls under the Gastroenterology category.

Other Devices by Luvo Medical Technologies, Inc.

K193446Bare: 808 K193072Lucent : IPL K210129RF Thermal System K203728Darwin

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.