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510(k) K052194

SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR by Boston Scientific Corp — Product Code ODF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2005
Date Received
August 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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).

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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)
  • 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)
  • K941230 — MINI-UB ENDOSCOPES (June 17, 1994)
  • K933106 — ENDOSCOPE (October 19, 1993)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K910732 — CANDELA MINI-UB ENDOSCOPE (April 12, 1991)