510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972612Substantially Equivalent

Dissectron Portable Unit

Satelec, Wellesley MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972612 is the FDA 510(k) clearance record for DISSECTRON PORTABLE UNIT, cleared for Satelec on under FDA product code LBK (Neurosurgical Ultrasonic Instruments). FDA records list 24 510(k) clearances for Satelec, from to . As of , FDA records show no recalls naming K972612.

Clearance record

Decision date
Received
(86 days to decision)
Product code
LBK Neurosurgical Ultrasonic Instruments
Device class
Unclassified
Review panel
Unknown
Applicant
Satelec 70 Walnut St., Wellesley MA
510(k) summary
Summary
Third party review
No

Clearances, product code LBK

Trailing 12 months

FDA records hold no clearances under product code LBK in the trailing twelve months.

FDA records show no clearances under product code LBK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LBK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260