Cleared Traditional

K991264 - SINGLE LUMEN SIDEPORT NEEDLE

K991264 is an FDA 510(k) clearance for SINGLE LUMEN SIDEPORT NEEDLE, manufactured by Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K991264 · Intl., Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 1999
Decision
149d
Days
Class 2
Risk

K991264 is an FDA 510(k) clearance for the <GENX> SINGLE LUMEN SIDEPORT NEEDLE. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Madison, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl., Inc. devices

FDA 510(k) Submission Details - K991264

510(k) Number K991264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date September 09, 1999
Days to Decision 149 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 160d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Intl., Inc.
MICHAEL D CECCHI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQE Needle, Assisted Reproduction

All 26
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K991264.
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
K992308 · Lifetek Medical, Inc. · Sep 1999
DOUBLE LUMEN NEEDLE
K991020 · Intl., Inc. · Sep 1999
SINGLE LUMEN NEEDLE
K991262 · Intl., Inc. · Sep 1999
SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
K991273 · Swemed Lab International AB · Aug 1999
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
K990913 · Laboratoires Prodimed · Jun 1999
OVUM PICK-UP ASPIRATION NEEDLES
K983593 · Cook Ob/Gyn · Jan 1999