510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101561Substantially Equivalent

Tx1 Tissue Removal System

Tenex Health, Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101561 is the FDA 510(k) clearance record for TX1 TISSUE REMOVAL SYSTEM, cleared for American Optisurgical, Inc. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 9 510(k) clearances for TENEX HEALTH, from to . As of , FDA records show 2 recalls naming K101561.

Clearance record

Decision date
Received
(84 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
American Optisurgical, Inc. 25501 Arctic Ocean, Lake Forest CA
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