Cleared Traditional

K960619 - MORE-L INJECTOR KIT PLUS

K960619 is an FDA 510(k) clearance for MORE-L INJECTOR KIT PLUS, manufactured by Incutech, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K960619 · Incutech, Inc. · Anesthesiology device
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Jun 1996
Decision
128d
Days
Class 2
Risk

K960619 is an FDA 510(k) clearance for the MORE-L INJECTOR KIT PLUS. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Incutech, Inc. (Greensboro, US). The FDA issued a Cleared decision on June 20, 1996 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5140 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Incutech, Inc. devices

FDA 510(k) Submission Details - K960619

510(k) Number K960619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date June 20, 1996
Days to Decision 128 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 140d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAZ Device Classification - Class 2, Special Controls

Product Code CAZ Anesthesia Conduction Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5140
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAZ Anesthesia Conduction Kit

All 109
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K960619.
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
K962880 · Sherwood Medical Co. · Dec 1996
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT
K962821 · Global Medical Products, Ltd. · Nov 1996
MEDCARE REGIONAL ANETHESIA KIT
K961075 · Medcare Medical Group, Inc. · Sep 1996
KENDALL BLUNT TUOHY EPIDURAL NEEDLE
K954706 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1996
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
K954953 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1996
SPINAL SPECIALTIES NERVE BLOCK TRAY
K960100 · Spinal Specialties, Inc. · Apr 1996