Medical Device Manufacturer · US , Burlingame , CA

Aesculap, Inc.

207 submissions · 201 cleared · Since 1991
207
Total
201
Cleared
0
Denied

Aesculap, Inc. — FDA 510(k) Submissions

Aesculap, Inc. has submitted 207 FDA 510(k) premarket notifications since 1991, of which 201 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Laparoscope, General & Plastic Surgery, Shunt, Central Nervous System And Components, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, Appliance, Fixation, Spinal Intervertebral Body . Use the specialty filter in the sidebar to narrow results.

207 devices
1–25 of 207
Aesculap Aicon? Series Container System
K242762 · KCT Sterilization Wrap... · General Hospital
May 2025 243d
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
K242003 · JXG Shunt, Central Nervous... · Neurology
Dec 2024 160d
SQ.line KERRISON
K223596 · HAE Rongeur, Manual · Neurology
Jun 2023 209d
Aesculap AICON Container
K214041 · KCT Sterilization Wrap... · General Hospital
Dec 2022 372d
Aesculap Slim Clip Applier
K211572 · HCI Applier, Aneurysm Clip · Neurology
Dec 2021 206d
ELAN 4 Electro Motor System
K203739 · HBE Drills, Burrs, Trephines... · Neurology
Aug 2021 245d
DIR 800
K202391 · IZI System, X-ray, Angiographic · Neurology
Jan 2021 153d
Aesculap Caiman 12 Seal and Cut Technology System
K203461 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2020 24d
Aesculap Caiman 5 Seal and Cut Technology System
K202938 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2020 30d
Aesculap PAS-Port Proximal Anastomosis System
K202124 · FZP Clip, Implantable · General & Plastic Surgery
Sep 2020 33d
Ventricular Catheter
K200950 · JXG Shunt, Central Nervous... · Neurology
May 2020 29d
JJ Series Container System
K192056 · KCT Sterilization Wrap... · General Hospital
Mar 2020 239d
SterilContainer S2 System
K193582 · KCT Sterilization Wrap... · General Hospital
Mar 2020 85d
M. Blue Adjustable Shunt System
K192266 · JXG Shunt, Central Nervous... · Neurology
Nov 2019 92d
ELAN 4 Tools
K183203 · HBE Drills, Burrs, Trephines... · Neurology
Aug 2019 263d
Aesculap? SterilContainer(TM) S2 System
K182414 · KCT Sterilization Wrap... · General Hospital
Jul 2019 304d
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K190174 · JXG Shunt, Central Nervous... · Neurology
Jul 2019 154d
Caiman 5 Maryland
K183180 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Mar 2019 113d
ELAN 4 Tools
K182527 · HBE Drills, Burrs, Trephines... · Neurology
Jan 2019 127d
SterilContainer S System
K182032 · KCT Sterilization Wrap... · General Hospital
Dec 2018 144d
ELAN 4 Air Motor System
K172907 · HBB Motor, Drill, Pneumatic · Neurology
Nov 2018 410d
ELAN 4 Electro Motor System Tools
K172709 · HBE Drills, Burrs, Trephines... · Neurology
Oct 2018 404d
Aesculap Slim Clip Applier
K180914 · HCI Applier, Aneurysm Clip · Neurology
Apr 2018 8d
Aesculap Optilene Nonabsorbable Suture
K180321 · GAW Suture, Nonabsorbable,... · General & Plastic Surgery
Mar 2018 30d
Aesculap Video Assisted Thoracic Surgery (VATS) INstruments
K170683 · GCJ Laparoscope, General &... · General & Plastic Surgery
Feb 2018 350d

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