Cleared Traditional

K033084 - WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER

K033084 is an FDA 510(k) clearance for WALLACE (SURE VIEW) EMBRYO REPLACEMENT ..., manufactured by Portex , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K033084 · Portex , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
81d
Days
Class 2
Risk

K033084 is an FDA 510(k) clearance for the WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Portex , Ltd. (Hyth, Kent, GB). The FDA issued a Cleared decision on December 19, 2003 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K033084

510(k) Number K033084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date December 19, 2003
Days to Decision 81 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
80d faster than avg
Panel avg: 161d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQF Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K033084.
IUI CATHETER, MODEL 9057
K052059 · Inntec, Inc. · Nov 2005
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
K050521 · Inntec, Inc. · May 2005
MORTON IUI CATHETERS
K041470 · Fertility Technology Resources, Inc. · Nov 2004
COOPERSURGICAL MALLEABLE SYTLET
K023382 · Cooper Surgical · Dec 2002
TUCKER EMBRYO CATHETER
K023017 · Fertility Technology Resources, Inc. · Dec 2002
COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
K023383 · Cooper Surgical · Dec 2002
K033084 · WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
Download PDF FDA Summary Portex , Ltd.