510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170064Unknown

Comaneci, Comaneci Petit, Comaneci 17

Rapid Medical Inc., Yokneam, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN170064 is the FDA 510(k) clearance record for Comaneci, Comaneci Petit, Comaneci 17, a class II device, cleared for Rapid-Medical , Ltd. on under FDA product code PUU (Temporary Coil Embolization Assist Device). FDA's definition for product code PUU reads: "A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into...". FDA records list 10 510(k) clearances for Rapid-Medical , Ltd., from to . As of , FDA records show no recalls naming DEN170064.

Clearance record

Decision date
Received
(573 days to decision)
Product code
PUU Temporary Coil Embolization Assist Device
Regulation
21 CFR 882.5955
Device class
Class II
Review panel
Neurology
Applicant
Rapid-Medical , Ltd. Carmel Bldg., Yokneam, IL
Third party review
No

Clearances, product code PUU

Trailing 12 months

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

FDA records show no clearances under product code PUU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PUU, 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