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

FDA 510(k)

Oclet TDS 1000

K-Number: K212049 · 2022-03-08

ApplicantTendonova Corporation
Decision Date2022-03-08
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Oclet TDS 1000 is a medical device manufactured by Tendonova Corporation. It received FDA 510(k) clearance on 2022-03-08 under approval number K212049. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oclet TDS 1000?

Oclet TDS 1000 is a medical device that received FDA 510(k) clearance on 2022-03-08. It is manufactured by Tendonova Corporation. The 510(k) number is K212049.

When was Oclet TDS 1000 approved by the FDA?

Oclet TDS 1000 received FDA 510(k) clearance on 2022-03-08, under approval number K212049.

What company makes Oclet TDS 1000?

Oclet TDS 1000 is manufactured by Tendonova Corporation.

What is the FDA product code for Oclet TDS 1000?

The FDA product code for Oclet TDS 1000 is LFL.

Related Devices (Code: LFL)

K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC K151136HARMONIC HOOKEthicon Endo-Surgery, LLC K153299Tenex Health TX SystemTenex Health, Inc. K172691Ultrasonic GeneratorOlympus Medical Systems Corp.

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.

↑