Cleared Traditional

AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR (K930867) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930867 · United States Surgical, A Division of Tyco Healthc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
521d
Days
Class 2
Risk

K930867 is an FDA 510(k) clearance for the AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on July 25, 1994 after a review of 521 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: 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.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K930867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1993
Decision Date July 25, 1994
Days to Decision 521 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
361d slower than avg
Panel avg: 160d · This submission: 521d
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 18
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K930867.
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
K171604 · Cook Incorporated · Feb 2018
uVue HSG/SHG Catheter
K160217 · Cook Incorporated · Oct 2016
PROBE HOLDER SYSTEM
K071405 · Intuitive Surgical, Inc. · Oct 2007
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
K935434 · United States Surgical, A Division of Tyco Healthc · May 1994
BARD UTERINE MANIPULATOR
K904079 · C.R. Bard, Inc. · Feb 1991