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Medical device manufacturer

ArthroCare Corporation

ArthroCare Corporation holds 149 FDA 510(k) clearances across 15 product codes. Median elapsed review time is 57 days. openFDA lists 14 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
149
Product codes
15
Median review
57 days
Recall records
14

How does FDA spell ArthroCare Corporation?

FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
ArthroCare Corporationdevice/enforcementnormalised
ArthroCare Corporationdevice/recallnormalised
ArthroCare Corporationdevice/registrationlistingnormalised
ArthroCare Corporationdevice/510knormalised
Arthrocare Corp.device/510knormalised
Arthrocare Corporationdevice/registrationlistingnormalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does ArthroCare Corporation file in?

15 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
GEIElectrosurgical, Cutting & Coagulation & Accessories8630 days
MBIFastener, Fixation, Nondegradable, Soft Tissue3160 days
HRXArthroscope772 days
NDNCement, Bone, Vertebroplasty672 days
FASElectrode, Electrosurgical, Active, Urological579 days
HWCScrew, Fixation, Bone473 days
OCWEndoscopic Tissue Approximation Device225 days
EKZUnit, Electrosurgical, And Accessories, Dental136 days
GATSuture, Nonabsorbable, Synthetic, Polyethylene158 days
GEYMotor, Surgical Instrument, Ac-Powered130 days
GXIProbe, Radiofrequency Lesion186 days
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)129 days
LRCInstrument, Ent Manual Surgical1115 days
LYASplint, Intranasal Septal160 days
OARInjector, Vertebroplasty (Does Not Contain Cement)163 days

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has ArthroCare Corporation had a recall?

openFDA lists 14 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

  • Z-2999-2020Class IIOpen, ClassifiedHXK

    Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.

  • Z-3000-2020Class IITerminatedGAT

    The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.

  • Z-1321-2016Class IITerminatedGEI

    During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.

  • Z-0623-2016Class IITerminatedGEI

    There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.

  • Z-2105-2015Class IITerminatedGEI

    Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.

Showing the 5 most recently initiated of 14.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has ArthroCare Corporation cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K254122FLOW FLEXTEND Wand (72290039)GEI101
K253680LYNX COBLATION Laryngeal Wand (72290254)GEI124
K240964FLOW 90? WandGEI29
K232290INTELLIO SHIFT SystemGEI132
K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)GEI87
K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION SystemGEI185
K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis WandGEI133
K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation SystemGEI150
K192027WEREWOLF COBLATION System, COBLATION HALO WandGEI144
K183346FLOW 90 WandGEI52

Source: openFDA device/510k · retrieved

Where is ArthroCare Corporation registered?

FDA lists 2 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what ArthroCare Corporation files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.