510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171851Substantially Equivalent

Softxil

Bistool Inc, Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171851 is the FDA 510(k) clearance record for SOFTXIL, a class II device, cleared for Bistool on under FDA product code MIB (Elastomer, Silicone Block). FDA records list one 510(k) clearance for Bistool. As of , FDA records show no recalls naming K171851.

Clearance record

Decision date
Received
(268 days to decision)
Product code
MIB Elastomer, Silicone Block
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Bistool 9, Gwangnaru-Ro 6-Gil, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MIB

Trailing 12 months

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

FDA records show no clearances under product code MIB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MIB, 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