Cleared Traditional

K943583 - KERRISON RONGEURS

K943583 is an FDA 510(k) clearance for KERRISON RONGEURS, manufactured by Enterprise Medical Corp.. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K943583 · Enterprise Medical Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
214d
Days
Class 2
Risk

K943583 is an FDA 510(k) clearance for the KERRISON RONGEURS. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Enterprise Medical Corp. (Greensboro, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 214 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - 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 Enterprise Medical Corp. devices

FDA 510(k) Submission Details - K943583

510(k) Number K943583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date February 21, 1995
Days to Decision 214 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 148d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAE Device Classification - Class 2, Special Controls

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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 - HAE Rongeur, Manual

All 14
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K943583.
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
K150428 · Integra Lifesciences Corp. · Apr 2015
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K092227 · Integra Lifesciences Corp. · Feb 2010
BRAY RONGEUR
K954699 · Johnson & Johnson Professionals, Inc. · Dec 1995
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · United States Surgical, A Division of Tyco Healthc · Jul 1994
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K892535 · Zinnanti Surgical Instruments, Inc. · May 1989