510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192278Substantially Equivalent

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

Uvision360, Inc., Raleigh NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192278 is the FDA 510(k) clearance record for Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic), a class II device, cleared for Uvision360, Inc. on under FDA product code HIH (Hysteroscope (And Accessories)). FDA records list 4 510(k) clearances for Uvision360, Inc., from to . As of , FDA records show no recalls naming K192278.

Clearance record

Decision date
Received
(71 days to decision)
Product code
HIH Hysteroscope (And Accessories)
Regulation
21 CFR 884.1690
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Uvision360, Inc. 158 Wind Chime Ct. ,Suite #201, Raleigh NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIH

Trailing 12 months
8 clearances under product code HIH in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code HIH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20261
September 20263
October 20260