Cleared Traditional

K990349 - WALLACE MALLEABLE STYLET-18CM

K990349 is the FDA 510(k) clearance for WALLACE MALLEABLE STYLET-18CM by CooperSurgical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQF) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K990349 · 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

K990349 is an FDA 510(k) clearance for the WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, M.... 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 K990349 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
Combination Product No
PCCP Authorized No
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 23
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K990349.
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 CATHETERS-18CM, MODEL 1816
K990350 · CooperSurgical, Inc. · Jul 1999
TRANSMYOMETRIAL EMBRYO TRANSFER SET
K983595 · Cook Ob/Gyn · Feb 1999
GIFT CATHETER SET/S
K983590 · Cook Ob/Gyn · Dec 1998