510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K100836Substantially Equivalent

Clearpoint System

Surgivision, Inc., Washington, D.C. DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100836 is the FDA 510(k) clearance record for CLEARPOINT SYSTEM, a class II device, cleared for Surgivision, Inc. on under FDA product code ORR (Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri). FDA's definition for product code ORR reads: "To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite". FDA records list 4 510(k) clearances for Surgivision, Inc., from to . As of , FDA records show no recalls naming K100836.

Clearance record

Decision date
Received
(84 days to decision)
Product code
ORR Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Surgivision, Inc. Columbia Sq., Washington, D.C. DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORR

Trailing 12 months

FDA records hold no clearances under product code ORR in the trailing twelve months.

FDA records show no clearances under product code ORR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ORR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260