Home / 510(k) Clearances / K933268

510(k) K933268

CANDELA GUIDEWIRE by Candela Laser Corp. — Product Code NWU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1994
Date Received
July 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope Introducer 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

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 NWU

  • K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER (December 3, 1987)
  • K813332 — BRISTOL BALLON INTRODUCER, MANDRIL SET (December 14, 1981)