Cleared Traditional

K923723 - SILICONE BRAIN SPATULA SET

K923723 is an FDA 510(k) clearance for SILICONE BRAIN SPATULA SET, manufactured by Redmond Neurosurgical, Inc.. The device is a Class 1 Neurology device with product code HAO cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K923723 · Redmond Neurosurgical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
16d
Days
Class 1
Risk

K923723 is an FDA 510(k) clearance for the SILICONE BRAIN SPATULA SET. Classified as Instrument, Surgical, Non-powered (product code HAO), Class I - General Controls.

Submitted by Redmond Neurosurgical, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on August 12, 1992 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4535 - the FDA neurology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Redmond Neurosurgical, Inc. devices

FDA 510(k) Submission Details - K923723

510(k) Number K923723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date August 12, 1992
Days to Decision 16 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 148d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

HAO Device Classification - Class 1, General Controls

Product Code HAO Instrument, Surgical, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4535
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HAO Instrument, Surgical, Non-powered

All 26
Devices cleared under the same product code (HAO) and FDA review panel - the closest regulatory comparables to K923723.
AUTO SUTURE SPINAL NERVE HOOK
K942969 · United States Surgical, A Division of Tyco Healthc · Jul 1994
AUTO SUTURE SPINAL ELEVATOR
K942970 · United States Surgical, A Division of Tyco Healthc · Jul 1994
AUTO SUTURE SPINAL DISSECTOR
K942971 · United States Surgical, A Division of Tyco Healthc · Jul 1994
TAYLOR SPINAL RETRACTOR
K892546 · Zinnanti Surgical Instruments, Inc. · May 1989
MALLEABLE PTFE COATED BRAIN SPATULAE
K880278 · Downs Surgical , Ltd. · Feb 1988
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS
K874630 · Downs Surgical , Ltd. · Dec 1987