Cleared Special

K080145 - PRIMAEVA MEDICAL SYSTEM

K080145 is an FDA 510(k) clearance for PRIMAEVA MEDICAL SYSTEM, manufactured by Primaeva Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 37-day FDA review.

K080145 · Primaeva Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
37d
Days
Class 2
Risk

K080145 is an FDA 510(k) clearance for the PRIMAEVA MEDICAL SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Primaeva Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on February 28, 2008 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Primaeva Medical, Inc. devices

FDA 510(k) Submission Details - K080145

510(k) Number K080145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2008
Decision Date February 28, 2008
Days to Decision 37 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1499
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K080145.
ERBE VIO ESU, MODEL VIO 200 S
K080715 · Erbe USA, Inc. · Apr 2008
ARTHROCARE ORTHOWAND SURGICAL DEVICE
K080610 · Arthrocare Corp. · Mar 2008
ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01
K080482 · Arthrocare Corp. · Mar 2008
ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504
K073046 · Ethicon Endo-Surgery, Inc. · Feb 2008
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
K073466 · Smith & Nephew, Inc. · Feb 2008
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00
K080282 · Arthrocare Corp. · Feb 2008