510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111013Substantially Equivalent

Acem

Diversatek Healthcare Inc, Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111013 is the FDA 510(k) clearance record for ACEM, a class II device, cleared for Sandhill Scientific, Inc. on under FDA product code FFZ (Cord, Electric, For Endoscope). FDA records list 20 510(k) clearances for DIVERSATEK HEALTHCARE INC, from to . As of , FDA records show no recalls naming K111013.

Clearance record

Decision date
Received
(252 days to decision)
Product code
FFZ Cord, Electric, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sandhill Scientific, Inc. 4655 Kirkwood Ct., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FFZ

Trailing 12 months

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

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