Atlas FDA

KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170

FDA 510(k) clearance K002221 · decided 2000-08-09

Clearance details

K-number
K002221
Device name
KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
Applicant
Heinz Kurz GmbH Medizintechnik
Decision
Substantially Equivalent
Date received
2000-07-24
Decision date
2000-08-09
Days to decision
16 days
Clearance type
Traditional
Product code
ETB
Device class
2
Regulation number
874.3450
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Amsterdam, Nh, NL
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.