Cleared Traditional

K932993 - INTRAUTERINE CATHETER AND INTRODUCER

K932993 is an FDA 510(k) clearance for INTRAUTERINE CATHETER AND INTRODUCER, manufactured by Conceptus, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MFD cleared through the Traditional 510(k) pathway after a 567-day FDA review.

K932993 · Conceptus, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
567d
Days
Class 2
Risk

K932993 is an FDA 510(k) clearance for the INTRAUTERINE CATHETER AND INTRODUCER. Classified as Cannula, Intrauterine Insemination (product code MFD), Class II - Special Controls.

Submitted by Conceptus, Inc. (San Carlos, US). The FDA issued a Cleared decision on January 6, 1995 after a review of 567 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K932993

510(k) Number K932993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1993
Decision Date January 06, 1995
Days to Decision 567 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
406d slower than avg
Panel avg: 161d · This submission: 567d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MFD Device Classification - Class 2, Special Controls

Product Code MFD Cannula, Intrauterine Insemination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5250
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 - MFD Cannula, Intrauterine Insemination

All 28
Devices cleared under the same product code (MFD) and FDA review panel - the closest regulatory comparables to K932993.
SELECT IUI
K954099 · Select Medical Systems, Inc. · Nov 1995
HUMAN TUBAL FLUID
K953719 · Life Technologies, Inc. · Nov 1995
MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE
K951835 · Life Technologies, Inc. · Aug 1995
LIFETEK IUI CATHETER
K921518 · Lifetek Medical, Inc. · May 1994
INSEMI-CATH
K931630 · Cook Ob/Gyn · Apr 1994
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
K914541 · Irvine Scientific · Feb 1994
K932993 · INTRAUTERINE CATHETER AND INTRODUCER
Download PDF FDA Summary Conceptus, Inc.