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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 the device name listed in this FDA 510(k) record. The listed applicant is Tendonova Corporation. It received FDA 510(k) clearance on 2022-03-08 under 510(k) 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. The listed applicant is Tendonova Corporation. The 510(k) number is K212049.

When did Oclet TDS 1000 receive FDA 510(k) clearance?

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

Who is the listed applicant for Oclet TDS 1000?

The FDA 510(k) record lists Tendonova Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oclet TDS 1000?

The FDA product code for Oclet TDS 1000 is LFL.

Related Devices (Code: LFL)

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.

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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.

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