510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K945191Substantially Equivalent

Endoscopic Accessory

Un-I-Med, Inc., Largo FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945191 is the FDA 510(k) clearance record for ENDOSCOPIC ACCESSORY, a class II device, cleared for Un-I-Med, Inc. on under FDA product code FAS (Electrode, Electrosurgical, Active, Urological). FDA records list 2 510(k) clearances for Un-I-Med, Inc., from to . As of , FDA records show no recalls naming K945191.

Clearance record

Decision date
Received
(191 days to decision)
Product code
FAS Electrode, Electrosurgical, Active, Urological
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Un-I-Med, Inc. 10401 Belcher Rd., Largo FL
510(k) summary
Summary
Third party review
No

Clearances, product code FAS

Trailing 12 months
1 clearance under product code FAS 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 FAS, 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