Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Delta III Pro

K-Number: K221903 · 2023-02-22

ApplicantDornier Medtech America, Inc.
Decision Date2023-02-22
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Delta III Pro is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221903. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Delta III Pro?

Delta III Pro is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K221903.

When did Delta III Pro receive FDA 510(k) clearance?

Delta III Pro received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221903.

Who is the listed applicant for Delta III Pro?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Delta III Pro?

The FDA product code for Delta III Pro is LNS.

Other records listing Dornier Medtech America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243820Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250K233380TRIDENT Mobile Fluoroscopy SystemK213252Dornier ThulioK220871NautilusK210394Electrosurgical accessoryK201815Dornier MAGELLAN Ureteral Access Sheath

View all 15 devices →

Related Devices (Code: LNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261086Break WaveSonomotion, Inc.K252913Break WaveSonomotion, Inc.K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd.K213772LM-9300 Plus LithotripterLite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy AmericaK201074Delta III LithotripterDornier Medtech America, Inc.

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.

↑