Cleared Traditional

K961923 - BERENSTEIN COIL

K961923 is an FDA 510(k) clearance for BERENSTEIN COIL, manufactured by Target Therapeutics. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961923 · Target Therapeutics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
90d
Days
Class 2
Risk

K961923 is an FDA 510(k) clearance for the BERENSTEIN COIL. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Target Therapeutics devices

FDA 510(k) Submission Details - K961923

510(k) Number K961923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date August 15, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCG Device Classification - Class 2, Special Controls

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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 Neurology devices follow this clearance model.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 171
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K961923.
CES VASCULAR OCCLUSION SYSTEM
K964367 · Cordis Neurovascular, Inc. · Jan 1997
GDC PATIENT RETURN ELECTTRODE MODEL 45021
K963307 · Target Therapeutics · Dec 1996
GUGLIELMI DETACHABLE COIL
K962503 · Target Therapeutics · Sep 1996
GUGLIELMI DETACHABLE COIL
K960705 · Target Therapeutics · May 1996
DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)
K951256 · Target Therapeutics · Sep 1995
TRUEFILL PVA PARTICLES
K951314 · Cordis Neurovascular, Inc. · Aug 1995