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<GEN>SINGLE LUMEN NEEDLE

K991262 Class II Traditional
Decision Date
1999-09-09
Sponsor / Applicant
<Genx> Intl., Inc.

Technical Specification

510(k) Submission ID K991262
Product Code MQE
Medical Specialty / Panel Obstetrics/Gynecology
Regulation Citation 21 CFR 884.6100
Decision Date 1999-09-09
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

<GEN>SINGLE LUMEN NEEDLE received FDA 510(k) clearance under submission number K991262, sponsored by <Genx> Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1999-09-09.

Classification & Regulation

This clearance is catalogued under FDA product code MQE and 21 CFR 884.6100, within the Obstetrics/Gynecology review panel as a Class II device.