TRUCLEAR OPERATIVE HYSTEROSCOPE


Device Classification Name

hysteroscope (and accessories)

510(k) Number K112134
Device Name TRUCLEAR OPERATIVE HYSTEROSCOPE
Applicant
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Applicant Contact janice haselton
Correspondent
SMITH & NEPHEW, INC.
150 minuteman rd.
andover, 
MA 
01810

Correspodent Contact janice haselton
Regulation Number 884.1690
Classification Product Code
HIH  
Date Received 07/27/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No