510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K915791Substantially Equivalent

Coritaxic Multi-Modal Stereotaxi Workstation

Coritechs, Inc., New Haven CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915791 is the FDA 510(k) clearance record for CORITAXIC MULTI-MODAL STEREOTAXI WORKSTATION, a class II device, cleared for Coritechs, Inc. on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list one 510(k) clearance for Coritechs, Inc. As of , FDA records show no recalls naming K915791.

Clearance record

Decision date
Received
(199 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Coritechs, Inc. 52 Whitney Ave., New Haven CT
510(k) summary
Statement
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