Cleared Traditional

K943116 - AUTO SUTURE KERRISON SPINAL RONGEUR

K943116 is an FDA 510(k) clearance for AUTO SUTURE KERRISON SPINAL RONGEUR, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K943116 · United States Surgical, A Division of Tyco Healthc · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
30d
Days
Class 2
Risk

K943116 is an FDA 510(k) clearance for the AUTO SUTURE KERRISON SPINAL RONGEUR. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on July 27, 1994 after a review of 30 days - a notably fast clearance 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: 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K943116

510(k) Number K943116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date July 27, 1994
Days to Decision 30 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
118d faster than avg
Panel avg: 148d · This submission: 30d
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.