Cleared Traditional

K890730 - MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 1000

K890730 is an FDA 510(k) clearance for MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULL..., manufactured by Medsurg Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CAZ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K890730 · Medsurg Industries, Inc. · Anesthesiology device
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Jun 1989
Decision
115d
Days
Class 2
Risk

K890730 is an FDA 510(k) clearance for the MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 1000. Classified as Anesthesia Conduction Kit (product code CAZ), Class II - Special Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on June 8, 1989 after a review of 115 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 Medsurg Industries, Inc. devices

FDA 510(k) Submission Details - K890730

510(k) Number K890730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1989
Decision Date June 08, 1989
Days to Decision 115 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
25d faster than avg
Panel avg: 140d · This submission: 115d
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 K890730.
MEDSURG EPIDURAL TRAY/19 GA/BUL TIP/17GA TUO 1002
K890731 · Medsurg Industries, Inc. · Jun 1989
MEDSURG EPIDURAL TRAY/BULLET TIP/17 GA TUOHY 1002E
K890732 · Medsurg Industries, Inc. · Jun 1989
MEDSURG EPIDURAL TRAY/19 GAGE OPEN END TUOHY 1012
K890733 · Medsurg Industries, Inc. · Jun 1989
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
K884552 · Arrow Intl., Inc. · Mar 1989
CURITY CONTINUOUS SPINAL ANESTHESIA TRAY
K885238 · The Kendal Co. · Feb 1989
PMT 3721-1 EPIDURAL KIT
K883314 · Progress Mankind Technology · Oct 1988