Cleared Traditional

K070360 - KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601

K070360 · Kirwan Surgical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
181d
Days
-
Risk

K070360 is an FDA 510(k) clearance for the KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40.... Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Kirwan Surgical Products, Inc. (Marshfield, US). The FDA issued a Cleared decision on August 7, 2007 after a review of 181 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kirwan Surgical Products, Inc. devices

FDA 510(k) Submission Details - K070360

510(k) Number K070360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2007
Decision Date August 07, 2007
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 125
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K070360.
INTEGRA(TM) CUSA NXT(TM) BONE TIPS
K111741 · Integra Burlington Ma, Inc. (Formerly Integra Radi · Aug 2011
HARMONIC FOCUS SHEARS
K100597 · Ethicon Endo-Surgery, LLC · Apr 2010
HARMONIC 10CM COMBINATION HOOK BLADE
K072203 · Ethicon Endo-Surgery, LLC · Sep 2007
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K070313 · Misonix, Inc. · May 2007
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP
K063192 · Ethicon Endo-Surgery, LLC · Jan 2007
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
K062471 · Misonix, Inc. · Oct 2006