Cleared Traditional

K051585 - F-400 SYSTEM

K051585 is an FDA 510(k) clearance for F-400 SYSTEM, manufactured by Mauna Kea Technologies. The device is a Class 2 General & Plastic Surgery device with product code GCJ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K051585 · Mauna Kea Technologies · General & Plastic Surgery device
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Sep 2005
Decision
83d
Days
Class 2
Risk

K051585 is an FDA 510(k) clearance for the F-400 SYSTEM. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Mauna Kea Technologies (Paris, FR). The FDA issued a Cleared decision on September 6, 2005 after a review of 83 days - a notably fast clearance cycle.

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: 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 Mauna Kea Technologies devices

FDA 510(k) Submission Details - K051585

510(k) Number K051585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2005
Decision Date September 06, 2005
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GCJ Device Classification - Class 2, Special Controls

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 803
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K051585.
MODULAR TROCAR SYSTEM
K060096 · Applied Medical Resources Corp. · Jan 2006
SPECIMEN RETRIEVAL SYSTEM
K060051 · Applied Medical Resources Corp. · Jan 2006
SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
K050209 · Smith & Nephew, Inc. · Nov 2005
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