510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K132611Substantially Equivalent

Microtable System

Fred Haer Company, Inc., Bowdoin ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132611 is the FDA 510(k) clearance record for MICROTABLE SYSTEM, a class II device, cleared for Fred Haer Company, Inc. on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list one 510(k) clearance for Fred Haer Company, Inc. As of , FDA records show no recalls naming K132611.

Clearance record

Decision date
Received
(198 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Fred Haer Company, Inc. 1201 Main St., Bowdoin ME
510(k) summary
Summary PDF
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