Cleared Traditional

K073664 - FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER

K073664 is an FDA 510(k) clearance for FRONTLINE MEDICAL SAFETYNET GUIDEWIRE I..., manufactured by Injectimed, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K073664 · Injectimed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
226d
Days
Class 1
Risk

K073664 is an FDA 510(k) clearance for the FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Injectimed, Inc. (Albuquerque, US). The FDA issued a Cleared decision on August 8, 2008 after a review of 226 days - an extended review 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: 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 Injectimed, Inc. devices

FDA 510(k) Submission Details - K073664

510(k) Number K073664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date August 08, 2008
Days to Decision 226 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 115d · This submission: 226d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

Product Code MDM Instrument, Manual, Surgical, General Use
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 - MDM Instrument, Manual, Surgical, General Use

All 11
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K073664.
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · Boston Scientific Corp · Nov 2002
SAPHLIFT
K990062 · Genzyme Surgical Product (Genzyme Biosurgery) · Mar 1999
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
K981579 · Ethicon, Inc. · Jul 1998
CLAMPS AND CLIPS
K942896 · Surgin Surgical Instrumentation, Inc. · Jul 1994
ORC ENDOSCOPIC INSTRUMENT HOLDER
K930399 · O.R. Concepts, Inc. · Feb 1993
LACERATION REPAIR TRAY
K921988 · Cypress Medical Products, Ltd. · Nov 1992