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510(k) K972979

SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM by Smith & Nephew, Inc. — Product Code FBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1997
Date Received
August 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystourethroscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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  • K061646 — LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES (June 27, 2006)
  • K011496 — CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENT (August 10, 2001)
  • K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (December 20, 1996)
  • K941992 — CYSTOSCOPE (November 30, 1995)