510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192703Substantially Equivalent

Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update

Brainlab, Inc., Munich, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192703 is the FDA 510(k) clearance record for Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update, a class II device, cleared for Brainlab AG on under FDA product code HAW (Neurological Stereotaxic Instrument). FDA records list 146 510(k) clearances for Brainlab AG, from to . As of , FDA records show no recalls naming K192703.

Clearance record

Decision date
Received
(377 days to decision)
Product code
HAW Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Brainlab AG Olof-Palme-Str 9, Munich, DE
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