510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991262Substantially Equivalent

<Gen>single Lumen Needle

<Genx> Intl., Inc., Madison CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991262 is the FDA 510(k) clearance record for <GEN>SINGLE LUMEN NEEDLE, a class II device, cleared for <Genx> Intl., Inc. on under FDA product code MQE (Needle, Assisted Reproduction). FDA records list 32 510(k) clearances for <Genx> Intl., Inc., from to . As of , FDA records show no recalls naming K991262.

Clearance record

Decision date
Received
(149 days to decision)
Product code
MQE Needle, Assisted Reproduction
Regulation
21 CFR 884.6100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
<Genx> Intl., Inc. 170 Fort Path Rd., Madison CT
510(k) summary
Summary
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