Cleared Traditional

K930038 - CANNULA: KAHN

K930038 is an FDA 510(k) clearance for CANNULA: KAHN, manufactured by Thomasville Medical Assoc.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 409-day FDA review.

K930038 · Thomasville Medical Assoc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
409d
Days
Class 2
Risk

K930038 is an FDA 510(k) clearance for the CANNULA: KAHN, JARCO, CORSON AND RATCHET. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Thomasville Medical Assoc. (Alpharetta, US). The FDA issued a Cleared decision on February 18, 1994 after a review of 409 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 Thomasville Medical Assoc. devices

FDA 510(k) Submission Details - K930038

510(k) Number K930038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date February 18, 1994
Days to Decision 409 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 160d · This submission: 409d
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 43
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K930038.
UTERINE INJECTOR WITH SPRING
K941457 · Zinnanti Surgical Instruments, Inc. · Jan 1995
AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR
K930867 · United States Surgical, A Division of Tyco Healthc · Jul 1994
OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
K935434 · United States Surgical, A Division of Tyco Healthc · May 1994
MAJOLI UTERINE MANIPULATOR/INJECTOR
K911887 · Cook Ob/Gyn · Jul 1991
BARD UTERINE MANIPULATOR
K904079 · C.R. Bard, Inc. · Feb 1991
TWIN BALLOON INJECTOR
K902975 · Zinnanti Surgical Instruments, Inc. · Sep 1990