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510(k) K912443

CANDELA INTRODUCER SHEATH SYSTEM by Candela Laser Corp. — Product Code FDE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1991
Date Received
June 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Candela Laser Corp.

  • K951033 — ANDELA DYNAMIC COOLING DEVICE (August 15, 1996)
  • K955662 — CANDELA Q-SWITCHED ALEXANDRITE LASERS (June 14, 1996)
  • K955011 — CANDELA HCS 2000 URETHERAL WARMER CATHETER (April 3, 1996)
  • K954872 — CANDELA CRYO-PROBE HOLDER (February 5, 1996)
  • K954934 — CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE (February 2, 1996)
  • K953412 — CANDELA MODEL PLTL-1 LASER SYSTEM (October 24, 1995)
  • K953294 — CANDELA CRYOSYSTEM CS-5 (October 18, 1995)
  • K950831 — ALEXLAZR (May 26, 1995)
  • K946386 — CANDELA RUBY LAZE Q-SWITCHED RUBY LASER (March 24, 1995)
  • K950661 — CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE (March 10, 1995)

Other clearances for product code FDE

  • K955717 — ENDOSCOPE INTRODUCER KIT (April 18, 1996)
  • K950924 — ASLAN KNOT PUSHER (March 14, 1995)
  • K942677 — GEENEN/ZEBRA GUIDELINES (July 21, 1994)