Cleared Traditional

K042834 - MICROMEDICS FIBRIJET AIR ASSISTED ENDOS...

K042834 is the FDA 510(k) clearance for MICROMEDICS FIBRIJET AIR ASSISTED ENDOS... by Micromedics, Inc.. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K042834 · Micromedics, Inc. · General & Plastic Surgery device
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Feb 2005
Decision
121d
Days
Class 2
Risk

K042834 is an FDA 510(k) clearance for the MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Micromedics, Inc. devices

Submission Details

510(k) Number K042834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2004
Decision Date February 11, 2005
Days to Decision 121 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 685
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K042834.
ENDOSCOPIC APPLICATOR
K051732 · Ethicon, Inc. · Aug 2005
ARMAND ENDOSCOPE HOLDER
K050051 · KLS-Martin L.P. · May 2005
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM
K050639 · Lumenis, Inc. · Mar 2005
MODIFIED SPACEMAKER SYSTEM
K042412 · United States Surgical, A Division of Tyco Healthc · Sep 2004
MODIFICATION TO OPTICAL SEPARATOR SYSTEM
K041795 · Applied Medical Resources Corp. · Sep 2004
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682
K041827 · Boston Scientific Corp · Aug 2004