510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K212049Substantially Equivalent

Oclet TDS 1000

TendoNova Corporation, Norcross GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212049 is the FDA 510(k) clearance record for Oclet TDS 1000, cleared for Tendonova Corporation on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list one 510(k) clearance for Tendonova Corporation. As of , FDA records show no recalls naming K212049.

Clearance record

Decision date
Received
(251 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Tendonova Corporation 3050 Business Park Dr., Suite A-2, Norcross GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFL

Trailing 12 months
1 clearance under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260