510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K993501Substantially Equivalent

3D1 Micropositioning Headstage

Scientific Tools, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993501 is the FDA 510(k) clearance record for 3D1 MICROPOSITIONING HEADSTAGE, a class II device, cleared for Scientific Tools, Inc. on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list one 510(k) clearance for Scientific Tools, Inc. As of , FDA records show no recalls naming K993501.

Clearance record

Decision date
Received
(38 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Scientific Tools, Inc. 12300 Twinbrook Pkwy., Suite 625, Rockville MD
510(k) summary
Summary
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