Cleared Traditional

K991273 - SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE

K991273 is an FDA 510(k) clearance for SWEMED FOLLICLE ASPIRATION SET, manufactured by Swemed Lab International AB. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K991273 · Swemed Lab International AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
127d
Days
Class 2
Risk

K991273 is an FDA 510(k) clearance for the SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Swemed Lab International AB (Washington, US). The FDA issued a Cleared decision on August 18, 1999 after a review of 127 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 Swemed Lab International AB devices

FDA 510(k) Submission Details - K991273

510(k) Number K991273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date August 18, 1999
Days to Decision 127 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
33d faster than avg
Panel avg: 160d · This submission: 127d
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 Peers - MQE Needle, Assisted Reproduction

All 21
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K991273.
DOUBLE LUMEN NEEDLE
K991020 · Intl., Inc. · Sep 1999
SINGLE LUMEN NEEDLE
K991262 · Intl., Inc. · Sep 1999
SINGLE LUMEN SIDEPORT NEEDLE
K991264 · Intl., Inc. · Sep 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