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510(k) K941230

MINI-UB ENDOSCOPES by Candela Laser Corp. — Product Code ODF

K941230 is an FDA 510(k) premarket notification submitted by Candela Laser Corp. for the device "MINI-UB ENDOSCOPES". The FDA issued a decision of Substantially Equivalent on June 17, 1994. The device falls under product code ODF (Mini Endoscope, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Candela Laser Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1994
Date Received
March 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mini Endoscope, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures in body cavities of the GI and GU tract. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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 ODF

  • K092739 — MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DU (January 12, 2010)
  • K091962 — POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOU (September 30, 2009)
  • K090170 — SPYSCOPE ACCESS AND DELIVERY CATHETER (February 4, 2009)
  • K052194 — SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR (August 24, 2005)
  • K050403 — SPYGLASS DIRECT VISULATION PROBE (March 4, 2005)
  • K963354 — 5 STAR MEDICAL ENDOSCOPE (September 8, 1997)
  • K943593 — SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM (March 22, 1995)
  • K933106 — ENDOSCOPE (October 19, 1993)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K910732 — CANDELA MINI-UB ENDOSCOPE (April 12, 1991)

FDA data resources