510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884415Substantially Equivalent

Ep-100 (Series)

Stereotactic Medical Systems, Inc., West Valley City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884415 is the FDA 510(k) clearance record for EP-100 (SERIES), a class II device, cleared for Stereotactic Medical Systems, Inc. on under FDA product code FPD (Tube, Feeding). FDA records list 5 510(k) clearances for Stereotactic Medical Systems, Inc., from to . As of , FDA records show no recalls naming K884415.

Clearance record

Decision date
Received
(131 days to decision)
Product code
FPD Tube, Feeding
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Stereotactic Medical Systems, Inc. 2801 So. 1935 W., West Valley City UT
Third party review
No

Clearances, product code FPD

Trailing 12 months

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

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