510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881132Substantially Equivalent

Laitinen's Trigeminus Stereoguide

Sandstrom Trade & Technology, Inc., Ontario L2n 7c5, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881132 is the FDA 510(k) clearance record for LAITINEN'S TRIGEMINUS STEREOGUIDE, a class II device, cleared for Sandstrom Trade & Technology, Inc. on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 2 510(k) clearances for Sandstrom Trade & Technology, Inc., from to . As of , FDA records show no recalls naming K881132.

Clearance record

Decision date
Received
(146 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Sandstrom Trade & Technology, Inc. 9 Mcnicholl Cir., St., Ontario L2n 7c5, CA
Third party review
No

Clearances, product code HAW

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