Cleared Traditional

K161547 - Transem and EchoGen Embryo Transfer Cat...

K161547 is the FDA 510(k) clearance for Transem and EchoGen Embryo Transfer Cat... by Origio A/S. It is a Class 2 Obstetrics & Gynecology device (product code MQF) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K161547 · Origio A/S · Obstetrics & Gynecology device
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Mar 2017
Decision
279d
Days
Class 2
Risk

K161547 is an FDA 510(k) clearance for the Transem and EchoGen Embryo Transfer Catheters. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Origio A/S (Måløv, DK). The FDA issued a Cleared decision on March 9, 2017 after a review of 279 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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 Origio A/S devices

Submission Details

510(k) Number K161547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2016
Decision Date March 09, 2017
Days to Decision 279 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 160d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQF Catheter, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
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 - MQF Catheter, Assisted Reproduction

All 24
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K161547.
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K172051 · Cook Incorporated · Jan 2018
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
K172321 · Cook Incorporated · Dec 2017
Soules Intrauterine Insemination Catheter
K163318 · Cook Incorporated · Jul 2017
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
K990348 · CooperSurgical, Inc. · Jul 1999
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
K990349 · CooperSurgical, Inc. · Jul 1999
WALLACE CATHETERS-18CM, MODEL 1816
K990350 · CooperSurgical, Inc. · Jul 1999