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510(k) K061646

LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES by Laserscope — Product Code FBO

K061646 is an FDA 510(k) premarket notification submitted by Laserscope for the device "LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on June 27, 2006. The device falls under product code FBO (Cystourethroscope), a Class II device regulated under 21 CFR 876.1500. Laserscope has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2006
Date Received
June 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Laserscope

  • K062719 — GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES (December 1, 2006)
  • K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES (March 30, 2004)
  • K024206 — AURA ISURGICAL LASER SYSTEM & ACCESSORIES (November 17, 2003)
  • K020021 — LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) (July 2, 2002)
  • K010834 — LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES (May 21, 2001)
  • K010284 — LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (May 1, 2001)
  • K003765 — LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) (March 6, 2001)
  • K003147 — LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) (December 15, 2000)
  • K990718 — ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) (March 8, 2000)
  • K990903 — LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) (August 27, 1999)

Other clearances for product code FBO

  • K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fibersc (May 2, 2025)
  • K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (November 27, 2024)
  • K131364 — FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE (January 2, 2014)
  • K082046 — KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND C (October 10, 2008)
  • K080780 — ANCHORAGE SCOPE, MODEL 000003 (July 30, 2008)
  • K062918 — KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM (January 17, 2007)
  • K011496 — CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENT (August 10, 2001)
  • K972979 — SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RI (December 11, 1997)
  • K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) (December 20, 1996)
  • K941992 — CYSTOSCOPE (November 30, 1995)

FDA data resources