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Medical device manufacturer

Aesculap, Inc.

Aesculap, Inc. holds 218 FDA 510(k) clearances across 74 product codes. Median elapsed review time is 90 days. openFDA lists 46 recall records naming the company. FDA publishes it under 12 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
218
Product codes
74
Median review
90 days
Recall records
46

How does FDA spell Aesculap, Inc.?

FDA publishes this company under 12 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
AESCULAP AGdevice/registrationlistingnormalised
AESCULAP SASdevice/registrationlistingnormalised
AESCULAP, INC.device/registrationlistingnormalised
Aesculapdevice/510knormalised
Aesculap AGdevice/recallnormalised
Aesculap AGdevice/enforcementnormalised
Aesculap Incdevice/recallnormalised
Aesculap Incdevice/enforcementnormalised

Showing 8 of 12.

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 Aesculap, Inc. file in?

74 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 & Accessories1833 days
GCJLaparoscope, General & Plastic Surgery1493 days
JXGShunt, Central Nervous System And Components13154 days
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories13233 days
KWQAppliance, Fixation, Spinal Intervertebral Body1187 days
HCHClip, Aneurysm1075 days
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid789 days
GWGEndoscope, Neurological790 days
FRGWrap, Sterilization6167 days
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer688 days
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)5245 days
HCIApplier, Aneurysm Clip587 days
FZPClip, Implantable416 days
HWCScrew, Fixation, Bone490 days
MNIOrthosis, Spinal Pedicle Fixation444 days
GARSuture, Nonabsorbable, Synthetic, Polyamide370 days
GAWSuture, Nonabsorbable, Synthetic, Polypropylene370 days
GXNPlate, Cranioplasty, Preformed, Non-Alterable376 days
GXQDura Substitute3265 days
HAWNeurological Stereotaxic Instrument390 days
HBCMotor, Drill, Electric390 days
HRXArthroscope3137 days
MNHOrthosis, Spondylolisthesis Spinal Fixation3152 days
MPNTissue Adhesive For The Topical Approximation Of Skin3210 days
NKBThoracolumbosacral Pedicle Screw System3216 days

Showing the 25 they file in most, of 74.

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 Aesculap, Inc. had a recall?

openFDA lists 46 recall records naming this company across its whole history, of which 7 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

  • Z-1485-2026Class IIOpen, ClassifiedGWG

    There is the potential for the length of the trocar shaft to be too long.

  • Z-0309-2026Class IIOpen, ClassifiedGCJ

    It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

  • Z-0310-2026Class IIOpen, ClassifiedGCJ

    It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

  • Z-0311-2026Class IIOpen, ClassifiedGCJ

    It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

  • Z-0312-2026Class IIOpen, ClassifiedGCJ

    It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

Showing the 5 most recently initiated of 46.

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 Aesculap, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K242762Aesculap Aicon® Series Container SystemKCT243
K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG160
K223596SQ.line KERRISONHAE209
K214041Aesculap AICON ContainerKCT372
K211572Aesculap Slim Clip ApplierHCI206
K203739ELAN 4 Electro Motor SystemHBE245
K202391DIR 800IZI153
K203461Aesculap Caiman 12 Seal and Cut Technology SystemGEI24
K202938Aesculap Caiman 5 Seal and Cut Technology SystemGEI30
K202124Aesculap PAS-Port Proximal Anastomosis SystemFZP33

Source: openFDA device/510k · retrieved

Where is Aesculap, Inc. registered?

FDA lists 4 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 Aesculap, Inc. 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.