510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K191512Unknown

LotusCatheter (Lotus No Balloon Catheter)

Hakki Medical Technologies, Inc., Largo FL / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191512 is the FDA 510(k) clearance record for LotusCatheter (Lotus No Balloon Catheter), a class II device, cleared for Hakki Medical Technologies, Inc. on under FDA product code GBM (Catheter, Urethral). FDA records list 2 510(k) clearances for Hakki Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K191512.

Clearance record

Decision date
Received
(349 days to decision)
Product code
GBM Catheter, Urethral
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Hakki Medical Technologies, Inc. 10333 Seminole Blvd., Suite #8, Largo FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GBM

Trailing 12 months

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

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