510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031758Substantially Equivalent

Acmi M4 Telescopes

Acmi Corporation, Southborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031758 is the FDA 510(k) clearance record for ACMI M4 TELESCOPES, a class II device, cleared for Acmi Corporation on under FDA product code FBP (Telescope, Rigid, Endoscopic). FDA records list 16 510(k) clearances for Acmi Corporation, from to . As of , FDA records show no recalls naming K031758.

Clearance record

Decision date
Received
(88 days to decision)
Product code
FBP Telescope, Rigid, Endoscopic
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Acmi Corporation 136 Tpke. Rd., Southborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FBP

Trailing 12 months

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

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