Cleared Traditional

K961752 - H/S CATHETER SET(61-3005

K961752 is an FDA 510(k) clearance for H/S CATHETER SET(61-3005, manufactured by Ackrad Laboratories. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K961752 · Ackrad Laboratories · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
94d
Days
Class 2
Risk

K961752 is an FDA 510(k) clearance for the H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607). Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on August 8, 1996 after a review of 94 days - within the typical 510(k) review window.

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: 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K961752

510(k) Number K961752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1996
Decision Date August 08, 1996
Days to Decision 94 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
66d faster than avg
Panel avg: 160d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 46
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K961752.
UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
K010056 · A & A Medical, Inc. · Feb 2001
PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
K000433 · Medical Device Technologies, Inc. · Jun 2000
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
K970492 · Ackrad Laboratories · Apr 1997
CONMED VCARE RETRACTOR/ELEVATOR
K955446 · Conmedcorp · Jun 1996
ROSCH -THURMOND FALLOPIAN TUBE CATHETERIZATION SET
K955508 · Cook Urological, Inc. · Feb 1996
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR) RETRACTOR/ELEVATOR
K946220 · Conmedcorp · Sep 1995