510(k) K090170

SPYSCOPE ACCESS AND DELIVERY CATHETER by Boston Scientific Corp — Product Code ODF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 4, 2009
Date Received: January 23, 2009
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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K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (October 18, 2024)
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K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX (August 30, 2024)
K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
K234002 — ICEfx Cryoablation System (FPRCH8000-02) (March 13, 2024)
K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Elec (November 28, 2023)

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)
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)
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)