Cleared Traditional

Oclet TDS 1000 (K212049) - FDA 510(k) Clearance

K212049 · Tendonova Corporation · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2022
Decision
251d
Days
-
Risk

K212049 is an FDA 510(k) clearance for the Oclet TDS 1000. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Tendonova Corporation (Norcross, US). The FDA issued a Cleared decision on March 8, 2022 after a review of 251 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Tendonova Corporation devices

Submission Details

510(k) Number K212049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2021
Decision Date March 08, 2022
Days to Decision 251 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 115d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Consultant

ProMedic Consulting, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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