Cleared Traditional

K013491 - HSG CATHETER SET

K013491 is the FDA 510(k) clearance for HSG CATHETER SET by A & A Medical, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code LKF) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K013491 · A & A Medical, Inc. · Obstetrics & Gynecology device
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Nov 2001
Decision
28d
Days
Class 2
Risk

K013491 is an FDA 510(k) clearance for the HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 19, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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.

View all A & A Medical, Inc. devices

Submission Details

510(k) Number K013491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date November 19, 2001
Days to Decision 28 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
132d faster than avg
Panel avg: 160d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - LKF Cannula, Manipulator/injector, Uterine

All 43
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K013491.
SIB CATHETER, MODEL 61-7005
K021272 · Ackrad Laboratories · May 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
K020954 · Ackrad Laboratories · Apr 2002
H/S CATHETER SET (5F), MODEL 61-5005
K020951 · Ackrad Laboratories · Apr 2002
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
K000433 · Medical Device Technologies, Inc. · Jun 2000
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
K970492 · Ackrad Laboratories · Apr 1997
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
K961752 · Ackrad Laboratories · Aug 1996