Cleared Traditional

K941458 - UTERINE MANIPULATOR/INJECTOR WITH SPRING

K941458 is an FDA 510(k) clearance for UTERINE MANIPULATOR/INJECTOR WITH SPRING, manufactured by Zinnanti Surgical Instruments, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K941458 · Zinnanti Surgical Instruments, 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
306d
Days
Class 2
Risk

K941458 is an FDA 510(k) clearance for the UTERINE MANIPULATOR/INJECTOR WITH SPRING. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on January 25, 1995 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K941458

510(k) Number K941458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1994
Decision Date January 25, 1995
Days to Decision 306 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
145d slower than avg
Panel avg: 161d · This submission: 306d
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 86
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K941458.
LUMIN
K943448 · Utah Medical Products, Inc. · Apr 1995
OVAMED HSG CATHETER
K931122 · Ovamed Corp. · Jan 1995
BERNSTEIN(TM) UTERINE MANIPULATOR
K932394 · Gm Engineering, Inc. · Jan 1995
UTERINE INJECTOR WITH SPRING
K941457 · Zinnanti Surgical Instruments, Inc. · Jan 1995
GODAT UTERINE MANIPULATOR INJECTOR
K935023 · Ideas For Medicine, Inc. · Jan 1995
CONCEPTUS UTERINE CATHETER
K933723 · Conceptus, Inc. · Dec 1994
K941458 · UTERINE MANIPULATOR/INJECTOR WITH SPRING
Download PDF FDA Summary Zinnanti Surgical Ins…