Cleared Special

K080482 - ARTHROCARE IRRIGATION PUMP

K080482 is the FDA 510(k) clearance for ARTHROCARE IRRIGATION PUMP by Arthrocare Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 27-day FDA review.

K080482 · Arthrocare Corp. · General & Plastic Surgery device
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Mar 2008
Decision
27d
Days
Class 2
Risk

K080482 is an FDA 510(k) clearance for the ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on March 20, 2008 after a review of 27 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 Arthrocare Corp. devices

Submission Details

510(k) Number K080482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2008
Decision Date March 20, 2008
Days to Decision 27 days
Submission Type Special
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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K080482.
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
K080093 · Gyrus Acmi, Inc. · May 2008
ERBE VIO ESU, MODEL VIO 200 S
K080715 · Erbe USA, Inc. · Apr 2008
ARTHROCARE ORTHOWAND SURGICAL DEVICE
K080610 · 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