510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050403Substantially Equivalent

Spyglass Direct Visulation Probe

Boston Scientific Corporation, Natick, MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050403 is the FDA 510(k) clearance record for SPYGLASS DIRECT VISULATION PROBE, a class II device, cleared for Boston Scientific Corp on under FDA product code ODF (Mini Endoscope, Gastroenterology-Urology). FDA's definition for product code ODF reads: "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...". FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K050403.

Clearance record

Decision date
Received
(15 days to decision)
Product code
ODF Mini Endoscope, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code ODF

Trailing 12 months

FDA records hold no clearances under product code ODF in the trailing twelve months.

FDA records show no clearances under product code ODF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260