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The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.

The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. Each clip applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.

The DIR 800 is an accessory for the Aesculap Aeos and is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency in neurosurgery. It also aids in the visual assessment of intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.

The DIR 800 is an accessory to the Aeos Digital Surgical Microscope Class I 510(k) exempt surgical operating microscope. The DIR 800 allows the Aeos to produce excitation light to illuminate the fluorescence properties of the Indocyanine Green (ICG). The generated fluorescence signal depicts the distribution of the infrared dye in the patient's blood vessels during surgery.

The catheter is used for cerebrospinal fluid (CSF) shunting.

The ventricular catheter is part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for shunting of excessive CSF. The ventricular catheter will be offered in lengths of 18 cm or 25 cm with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. The ventricular catheter contains five stripe depth markers at 3, 5, 7, 10 and 13 cm from the catheter tip. The ventricular catheter is manufactured using barium sulfate filled silicone elastomer. The purpose of this submission is to seek clearance for modifications to the ventricular catheter which is part of the Miethke Shunt System (K020728). This submission proposes the following modification: - adding stripe depth markers at 4, 6, 8, 9, 11 and 12 cm and point markers at 1 cm intervals on both sides of the tubing starting at 3.5 cm to 12.5 cm from the catheter tip. The ventricular catheter is designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System, Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System, proSA Progammable Shunt System, Miethke Shunt System miniNAV valve, Miethke Shunt System Gravity Assisted Valve (GAV), and the Miethke Shunt System (DSV, ShuntAssistant, paedi-GAV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K120559/K110206/K103003/K062009/K031303/ K030698/K011030).

The Aesculap JJ Series Container System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the tables below. The JJ Series Container System container styles: a solid bottom container and enhanced drying system (EDS) container. The Aesculap JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. The attached tables identifies the load configurations.

The Aesculap JJ Series Container System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in Prevac steam with and without dry time. The JJ Series Container System consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container. The containers are made from anodized aluminum and utilize a single-use filter. The JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.

The Aesculap SterilContainer™ S2 System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in the following sterilization modalities: - Ethylene Oxide - STERRAD 100NX DUO cycle - . STERIZONE VP4 The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.

The Aesculap SterilContainer S2 System is a reusable rigid container system intended for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities: - Ethylene Oxide ● - STERRAD 100NX DUO cycle - STERIZONE VP4 ● The containers are perforated and made from anodized aluminum and utilize a single-use filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.

The M.blue Adjustable Shunt System is used for cerebrospinal fluid (CSF) shunting.

M.blue is an adjustable valve that combines an adjustable gravitational unit and a fixed differential pressure unit. The M.blue valve can be set for a range of pressures and is offered in four pressure level settings. The M.blue valve is comprised of a titanium housing enclosed by a thin titanium membrane with a curved wave profile design. The gravitational unit of the M.blue valve contains a tantalum weight, leaf spring and ball mechanically controlled by internal magnets. The differential pressure unit (ball-in-cone) of the M.blue valve contains a sapphire ball and titanium spring. Manual devices are available to locate, verify the pressure setting and to set or change the pressure pre and postoperatively. These manual accessories are for external use by the Healthcare provider. The M.blue valve will be distributed by itself or in combination with the proGAV 2.0 valve. The M.blue valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.

Aesculap ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery

The ELAN 4 Tools are cutting devices designed for use with the ELAN 4 Electro Motor System. The ELAN 4 Tools are designed for cutting, sawing and drilling of bone. The ELAN 4 Tools have an attachment mechanism designed specifically for the type of motors and attachments with which they will be used. The ELAN 4 Tools are manufactured from stainless steel with some tools containing a coated layer of diamond chips. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System (K152960).

The Aesculap(R) SterilContainer™ S2 System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in the following sterilization modalities: - Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time) - Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time) - STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles - STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles. The Aesculap SterilContainer S2 System includes accessories such as sillcone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks. The attached table identifies the validated load configurations for each of the modalities.

The Aesculap SterilContainer S2 System is a reusable rigid container system that will allow for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities: - Dynamic-air removal steam (PreVac) (270°F for 4 minutes with 15 minute dry time) - Gravity Steam (250°F for 30-60 minutes with 15 minute dry time) - STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD ● 100NX Standard, STERRAD 100NX Flex Cycles - STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX . Lumen, V-PRO maX Non-Lumen, V-PRO maX Flex cycles The containers are perforated and made from anodized aluminum and utilize a single-use or reusable filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.

The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.

The Aesculap Miethke Shunt System is used in the treatment of hydrocephalus. Components of the Miethke Shunt System can include the GAV (Gravity Assisted Valve) 2.0 valve and SA (SHUNTASSISTANT) 2.0 valve. The GAV 2.0 is a posture dependent, fixed gravitational valve that combines a differential pressure unit and gravitational unit. This combination allows an automatic adjustment of the opening pressure according to the patient's different body position and is used to control overdrainage. The housing of the GAV 2.0 valve is manufactured from titanium. The GAV 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The GAV 2.0 valve is available as a single device as well as with various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs. The SA 2.0 valve is a posture dependent gravitational valve and is used to control overdrainage. The SA 2.0 is designed for use in combination with an adjustable or non-adjustable differential pressure valve to add increased resistance to the shunt system as a patient changes position. housing of the SA 2.0 valve is manufactured from titanium. The SA 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The SA 2.0 valve is available as a single device as well as with the proGAV 2.0 valve and various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.

Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue. Instruments 12.5 cm, 17 cm, and 24 cm in length are indicated for open procedures and instruments 36 cm and 44 cm in length are indicated for laparoscopic procedures. The include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices up to and including 7mm and bundles as large as will fit in the jaws of the instrument. Caiman Seal and Cut Technology has not be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

The Caiman® 5 Maryland instruments are seal and cut devices which are provided as sterile, single use devices. These devices are capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The devices are designed to be used with the dedicated Lektrafuse RF Generator and create vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.