510(k) K941230

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

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)