510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232163Substantially Equivalent

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

Zhejiang Horizon Medical Technology Co., Ltd., Jiaxing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232163 is the FDA 510(k) clearance record for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle, a class II device, cleared for Zhejiang Horizon Medical Technology Co., Ltd. on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 2 510(k) clearances for Zhejiang Horizon Medical Technology Co., Ltd., from to . As of , FDA records show no recalls naming K232163.

Clearance record

Decision date
Received
(216 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Zhejiang Horizon Medical Technology Co., Ltd. Rm. 219, 2nd Floor, Bldg. 9, 1303 Asia-Pacific Rd., Jiaxing, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQE

Trailing 12 months
1 clearance under product code MQE in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260