FDA.report

510(k) K223596

Device
SQ.line KERRISON
Applicant
Aesculap, Inc.
510(k) number
K223596
Product code
HAE
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-29
Date received
2022-12-02
Regulation
882.4840
Classification name
Rongeur, Manual
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Benjamin Oswald
Address
3773 Corporate Pkwy. Center Valley PA US 18034 18034

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K131851OSTEOMED NEURO RONGEUROsteomed2013-12-06
K130541SYMMETRY KERRISON DISPOSABLE TIP RONGEURSSymmetry Surgical2013-08-05