510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012232Substantially Equivalent

Insight, Model S980000

Diversatek Healthcare Inc, Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012232 is the FDA 510(k) clearance record for INSIGHT, MODEL S980000, a class II device, cleared for Sandhill Scientific, Inc. on under FDA product code FFX (System, Gastrointestinal Motility (Electrical)). FDA records list 20 510(k) clearances for DIVERSATEK HEALTHCARE INC, from to . As of , FDA records show 2 recalls naming K012232.

Clearance record

Decision date
Received
(326 days to decision)
Product code
FFX System, Gastrointestinal Motility (Electrical)
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sandhill Scientific, Inc. 4655 Kirkwood Ct., Boulder CO
510(k) summary
Statement
Third party review
No

Clearances, product code FFX

Trailing 12 months
1 clearance under product code FFX in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FFX, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260