Cleared Traditional

K003965 - MRI SAFE INSTRUMENTS

K003965 is an FDA 510(k) clearance for MRI SAFE INSTRUMENTS, manufactured by Aesculap, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K003965 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
84d
Days
Class 1
Risk

K003965 is an FDA 510(k) clearance for the MRI SAFE INSTRUMENTS. Classified as Cannula, Surgical, General & Plastic Surgery (product code GEA), Class I - General Controls.

Submitted by Aesculap, Inc. (Allentown, US). The FDA issued a Cleared decision on March 16, 2001 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K003965

510(k) Number K003965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2000
Decision Date March 16, 2001
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

GEA Device Classification - Class 1, General Controls

Product Code GEA Cannula, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEA Cannula, Surgical, General & Plastic Surgery

All 17
Devices cleared under the same product code (GEA) and FDA review panel - the closest regulatory comparables to K003965.
GENICON TROCAR
K982472 · Genicon, LC · Feb 1999
CONMED TROGARD ELECTRONIC TROCAR SYSTEM
K954599 · Conmedcorp · Nov 1995
ORIGIN SECONDARY CANNULA AND TROCAR
K922460 · Origin Medsystems, Inc. · Sep 1992
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
K920110 · Ethicon, Inc. · Apr 1992
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · Ethicon, Inc. · Jun 1991
SUCTION SYSTEM
K904218 · Axiom Medical, Inc. · Oct 1990