Cleared Traditional

K960100 - SPINAL SPECIALTIES NERVE BLOCK TRAY

K960100 is an FDA 510(k) clearance for SPINAL SPECIALTIES NERVE BLOCK TRAY, manufactured by Spinal Specialties, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K960100 · Spinal Specialties, Inc. · Anesthesiology device
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Apr 1996
Decision
104d
Days
Class 2
Risk

K960100 is an FDA 510(k) clearance for the SPINAL SPECIALTIES NERVE BLOCK TRAY. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Spinal Specialties, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 24, 1996 after a review of 104 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 Spinal Specialties, Inc. devices

FDA 510(k) Submission Details - K960100

510(k) Number K960100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date April 24, 1996
Days to Decision 104 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
36d faster than avg
Panel avg: 140d · This submission: 104d
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 K960100.
MORE-L INJECTOR KIT PLUS
K960619 · Incutech, Inc. · Jun 1996
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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
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
K954835 · Holgrath Medical Technologies, Inc. · Jan 1996
MORELL INJECTOR
K951870 · Incutech, Inc. · Jan 1996
BD PERISAFE EPIDURAL ANESTHESIA TRAY
K953790 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1995