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Medical device manufacturer

Codman & Shurtleff, Inc.

Codman & Shurtleff, Inc. holds 153 FDA 510(k) clearances across 61 product codes. Median elapsed review time is 67 days. openFDA lists 78 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
153
Product codes
61
Median review
67 days
Recall records
78

How does FDA spell Codman & Shurtleff, Inc.?

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
Codman & Shurtleff Incdevice/enforcementnormalised
Codman & Shurtleff Incdevice/recallnormalised
Codman & Shurtleff, Inc.device/enforcementnormalised
Codman & Shurtleff, Inc.device/recallnormalised
Codman & Shurtleff, Inc.device/510knormalised
Codman and Shurtleff, Inc.device/510knormalised

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 Codman & Shurtleff, Inc. file in?

61 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
JXGShunt, Central Nervous System And Components2358 days
GWMDevice, Monitoring, Intracranial Pressure974 days
DQYCatheter, Percutaneous830 days
HCGDevice, Neurovascular Embolization867 days
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)676 days
GEIElectrosurgical, Cutting & Coagulation & Accessories541 days
HBLHolder, Head, Neurosurgical (Skull Clamp)5129 days
GZJStimulator, Nerve, Transcutaneous, For Pain Relief448 days
HCHClip, Aneurysm434 days
JDGProsthesis, Hip, Femoral Component, Cemented, Metal413 days
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered332 days
GEXPowered Laser Surgical Instrument3162 days
GWGEndoscope, Neurological3229 days
HCACatheter, Ventricular390 days
JDQCerclage, Fixation3117 days
JEYPlate, Bone390 days
KPMShunt, Peritoneal3123 days
DQXWire, Guide, Catheter232 days
DWSInstruments, Surgical, Cardiovascular27 days
GCQEndoscope, Flexible295 days
GXQDura Substitute215 days
HAOInstrument, Surgical, Non-Powered28 days
HBMHeadrest, Neurosurgical278 days
HBOClip, Scalp279 days
HLJOphthalmoscope, Battery-Powered211 days

Showing the 25 they file in most, of 61.

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 Codman & Shurtleff, Inc. had a recall?

openFDA lists 78 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-2280-2019Class IITerminatedHCG

    Incorrect coil length on the label

  • Z-1571-2014Class IITerminatedLKK

    A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

  • Z-1572-2014Class IITerminatedLKK

    A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

  • Z-1684-2015Class IITerminatedLKK

    Needle is leaking from hub/needle cannula connection

  • Z-0089-2015Class IITerminatedJXG

    tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)

Showing the 5 most recently initiated of 78.

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 Codman & Shurtleff, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY228
K191237CERENOVUS Large Bore CatheterDQY184
K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitGWM37
K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagJXG55
K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG90
K171862GALAXY G3 Mini Microcoil Delivery SystemHCG95
K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery SystemHCG31
K171653YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY28
K162563YOGA MicrocatheterDQY113
K162437Codman EDS3 CSF External Drainage SystemJXG58

Source: openFDA device/510k · retrieved

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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.