Cleared Special

K180848 - AMBIENT Super MULTIVAC 50 Wand with Int...

K180848 is the FDA 510(k) clearance for AMBIENT Super MULTIVAC 50 Wand with Int... by ArthroCare Corporation. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 29-day FDA review.

K180848 · ArthroCare Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
29d
Days
Class 2
Risk

K180848 is an FDA 510(k) clearance for the AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches. 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 Corporation (Austin, US). The FDA issued a Cleared decision on May 1, 2018 after a review of 29 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 Corporation devices

Submission Details

510(k) Number K180848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2018
Decision Date May 01, 2018
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 K180848.
DiLumen Endolumenal Interventional Scissors (DiLumen Is)
K173405 · Lumendi, LLC · May 2018
Irrigation Tubing Bipolar Cord Set
K180908 · New Deantronics Taiwan , Ltd. · May 2018
Endopath Electrosurgery Probe Plus II
K180031 · Ethicon Endo-Surgery, LLC · May 2018
ESG-300, APU-300, Pressure Reducer, MAPC Probes
K180200 · Olympus Winter & Ibe GmbH · Apr 2018
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
K172610 · Olympus Medical Systems Corp. · Apr 2018
Voyant Open Fusion Device
K180699 · Applied Medical Resources Corporation · Apr 2018