Cleared Special

K013972 - H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005

K013972 is an FDA 510(k) clearance for H/S ELLIPTOSPHERE CATHETER SET, manufactured by Ackard Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Special 510(k) pathway after a 14-day FDA review.

K013972 · Ackard Laboratories · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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Dec 2001
Decision
14d
Days
Class 2
Risk

K013972 is an FDA 510(k) clearance for the H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Ackard Laboratories (Cranford, US). The FDA issued a Cleared decision on December 17, 2001 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ackard Laboratories devices

FDA 510(k) Submission Details - K013972

510(k) Number K013972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date December 17, 2001
Days to Decision 14 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 160d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

LKF Device Classification - Class 2, Special Controls

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 61
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K013972.
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
SF SH CATHETER, MODEL R65-945
K013437 · A & A Medical, Inc. · Nov 2001
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
K013491 · A & A Medical, Inc. · Nov 2001
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
K010056 · A & A Medical, Inc. · Feb 2001