Cleared Traditional

WALLACE CATHETERS-18CM, MODEL 1816 (K990350) - FDA 510(k) Clearance

Also marketed or referenced as:
23CM, MODEL 1816N 23CM, MODEL 2316

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990350 · CooperSurgical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
171d
Days
Class 2
Risk

K990350 is an FDA 510(k) clearance for the WALLACE CATHETERS-18CM, MODEL 1816. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on July 26, 1999 after a review of 171 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 CooperSurgical, Inc. devices

Submission Details

510(k) Number K990350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1999
Decision Date July 26, 1999
Days to Decision 171 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
11d slower than avg
Panel avg: 160d · This submission: 171d
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 52
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K990350.
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
K253354 · Guangzhou Hehong Biotech Co., Ltd. · Feb 2026
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500)
K243373 · Vitrolife Sweden AB · Jul 2025
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
K240307 · Shenzhen Vitavitro Biotech Co., Ltd. · Aug 2024
FemaSeed Intratubal Insemination
K231730 · Femasys, Inc. · Sep 2023
Daylily Single Use Sterile Embryo Transfer Catheter
K220010 · Shanghai Horizon Medical Technology Co., Ltd. · Dec 2022
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
K200248 · Allwin Medical Devices, Inc. · Jul 2020