Cleared Traditional

K896799 - PARACERVICAL/PUDENDAL TRAYS

K896799 is an FDA 510(k) clearance for PARACERVICAL/PUDENDAL TRAYS, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K896799 · Westmark, Sterile Packing Systems, Inc. (Sps) · Anesthesiology device
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Apr 1990
Decision
143d
Days
Class 2
Risk

K896799 is an FDA 510(k) clearance for the PARACERVICAL/PUDENDAL TRAYS. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 143 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 Westmark, Sterile Packing Systems, Inc. (Sps) devices

FDA 510(k) Submission Details - K896799

510(k) Number K896799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date April 23, 1990
Days to Decision 143 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 140d · This submission: 143d
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 100
Devices cleared under the same product code (CAZ) and FDA review panel - the closest regulatory comparables to K896799.
CURITY NERVE BLOCK TRAY
K903887 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1990
CURITY PEDIATRIC CONTINUOUS CAUDAL ANESTHESIA TRAY
K902647 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1990
COSPAN PEDIATRIC CONTINUOUS SPINAL ANESTHESIA TRAY
K902312 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1990
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717
K896392 · Medtronic Vascular · Nov 1989
HIBERNATION KIT
K892660 · Devon Industries, Inc. · Aug 1989
CONTINUOUS EPIDURAL ANESTHESIA TRAY
K893938 · Medsurg Industries, Inc. · Aug 1989