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The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatio, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to. Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy. The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

The POWERSEAL 5mm laparoscopic jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and is provided in shaft lengths of 23, 37, and 44 cm. The POWERSEAL devices will be provided as sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. The jaws of the POWERSEAL are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using radiofrequency (RF) energy, otherwise known as high frequency (HF) energy. A hand-actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over the tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a separate control to activate a blade, which divides the tissue along the seal line.

The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser. producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam. The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns. The system includes: - Laser console - Laser fibers sterile single use and reusable - Foot pedal, wireless or wired - Accessories power cord. HDMI cable, safety goggles/glasses, fiber cutter, fiber cleaver, fiber stripper and cart The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.

The Celeris System (reusable power pack and Disposable Sinus Debrider) is intended for cutting, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures and applications would include: · FESS (Functional Endoscopic Sinus Surgery) – Including Endoscopic approaches for: Polypectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy · Turbinate Reduction / Turbinoplasty, including sub-mucosal resection.

The Celeris DSD handpiece is a single-use disposable debrider handle and blade permanently combined with a built-in motor that plugs into a reusable power pack that contains a power supply for motor control. The power pack is also part of the subject system. The power supply is able to auto-adapt to any voltage via the universal power cord connection. Motor control requires software on a controller board inside the power pack. The handpiece incorporates a rotatable blade and attached RF cable for bipolar models. The blades are either standard, bipolar, or malleable. The bipolar function requires a separate electrosurgical generator (not part of this system), connected via a cable. The cutting performance is equivalent to the current Gyrus ACMI predicate models. A trigger style button on the DSD handle, or analog footswitch (sold separately) connected to the power pack, activates the blade oscillation and a standard electrosurgical unit footswitch (sold separately) powers the binolar effect for bipolar blades. The electrosurgical generator and footswitch alone will control the RF energy delivery. A nosecone on the DSD handpiece allows the blade cutting window to rotate left or right. The blades are offered in 2mm and 4mm variants, either straight or malleable, and standard or bipolar. The malleable blade angle is flexible, and the design allows the blade to be bent with the provided bending fixture up to 60° at the user's discretion. A standard suction tube (sold separately) is attached to the DSD handpiece proximal suction port and a clip attaches the tubing to the power cable. The handpiece power cable plugs directly into the power pack. The non-sterile power pack plugs into a standard power outlet and only provides power to the connected DSD handpiece. When the handpiece is activated power is sent to the motor which oscillates a gear which in turn oscillates the inner blade. For bipolar models, the energy lead from the cable is connected directly to the blade and energy is provided by the separate electrosurgical generator footswitch. For bipolar models, insulation around the cutting window limits energy delivery to the surgical site.

1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures. 2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. 3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.

The Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook are bipolar electrosurgical instruments with the capability to resect, cut, and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. They pass through a 5mm cannula or operating laparoscope working channel of 5mm or larger diameter. The devices are activated via buttons on the handle or by a foot pedal and plug into compatible Olympus generators (ESG-400 and ESG-410). The generator and device make up a medical electrical system.

The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology: · Ablation of Benign Prostatic Hypertrophy) [BPH]• Laser Resection of the Prostrate (LRP)• Laser Enucleation of the Prostate (LEP) · Laser Ablation of the Prostate (LAP) · Transurethral Incision of the Prostate (TUIP) · Condylomas · Urethral strictures · Lesions of external genitalia · Bladder neck incisions (BN) · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors Endoscopic fragmentation of ureteral, bladder, and renal calculi• Treatment of distal impacted fragments remaining in the ureters following lithotripsy Lithotripsy and Percutaneous Urinary Lithotripsy Indications: · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones • Endoscopic fragmentation of calculi • Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology: Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including: · Appendectomy · Angiodysplasia · Polyps · Colorectal cancer · Biopsy · Telangiectasias • Gall Bladder calculi • Telangiectasias of the Osler-Weber-Renu disease • Biliary/Bile duct calculi • Vascular Malformation . Ulcers . Gastric ulcers . Esophagitis . Duodenal ulcers . Esophageal ulcers . Non Bleeding Ulcers · Varices · Pancreatitis · Colitis · Haemorrhoids · Mallory-Weiss tear · Cholecystectomy · Gastric Erosions • Benign and Malignant Neoplasm Gynecology: Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue

The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser, producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam. The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns. The system includes: - Laser console ● - Laser fibers sterile single use and reusable ● - Foot pedal, wireless or wired ● - Accessories power cord, HDMI cable, safety goggles/glasses, fiber cutter, . - fiber cleaver, fiber gripper, sterilization trav, cart . The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.

The Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters are in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

Both the predicate and proposed Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheters consist of a semi-compliant nylon blow molded balloon; and, a shaft that communicates a fluid passage for expansion and collapse of the balloon portion, operated by an inflation device. Like the predicate, the EZDilate Wire Guided Balloon is designed to be used with a 0.035 in. (0.89mm) guidewire and has a wire lumen sized appropriately. Each balloon catheter is packaged with a soft tip 0.035 in. (0.89mm) guidewire pre-loaded into the guidewire lumen. The guidewire is manufactured by Lake Region Medical; and, is cleared under K935198, Gastroenterology and Urology Guidewire Modifications. All wire-guided balloons with have lengths of 5.5cm and a catheter length of 240cm. The balloon is inflated with a 60cc inflation device, which will be sold separately. The suggested inflation device is manufactured by Atrion (K032840). The Gyrus ACMI EZDilate 3-StageWire Guided Balloon Dilatation Catheter is a reinforced catheter attached to a distal dilatation balloon. The semi-compliant balloon allows for a progressive radial expansion through three target sizes using one balloon. A silicone coating applied to the balloon increases ease of insertion, positioning of the balloon within the alimentary tract, and device removal.

The PK Morcellator is intended for cutting, and extracting tissue in laparoscopic gynecologic procedures. It is recommended to use the PK Morcellator in containment device (WA90500US) for removal of uterine tissue.

The proposed PK Morcellator is configured in an ergonomically friendly pistol grip configuration, and includes an axially oriented hollow shaft. The pistol grip integrates the electrical connection cable that allows bipolar RF energy to be supplied by the electrosurgical generator to the tissue site located at the distal end of the hollow shaft. The design of the pistol grip body is such that a clinician mav utilize a "ski-pole" grip on the Morcellator body, if that is their preference. The proposed PK Morcellator incorporates an improved smoke evacuation system to provide improved visibility during procedures. Smoke management can alternate between intermittent or constant by activating a trigger lock on the handle. The hollow shaft of the Morcellator has an operative length of approximately 15 cm, extending distally from the pistol grip body. The surface of the Morcellator shaft is smooth, allowing the device to be introduced to the operative site through a trocar cannula seal, or with the use of the optional obturator, through an abdominal port. To facilitate optimal placement of the device during laparoscopic procedures, a depth stop normally located at the distal end of the pistol grip (at the junction of the pistol grip and Morcellator shaft), may be moved distally along the Morcellator shaft. The shaft has a nominal outer diameter of 15 mm. and a nominal inner diameter of 12 mm. The proximal end of the shaft also includes an elastomeric reducer that permits the passage of a grasper to the operative site and removal of tissue from the operative site, while preventing loss of pnuemoperitoneum.

Intended to clear the end of a rigid rod endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.

The InstaClear Lens Cleaner system is equivalent to the predicate device cleared under K982594. The system includes a reusable AC powered console with pump, a reusable footpedal, and sterile disposable single-use accessories. The system is used to clear the end of a rigid endoscope in order to maintain clear visualization of endoscopic procedures without having to remove the scope from the surgical site. The device is indicated for use during routine diagnostic procedures and during endoscopic sinus surgery (ESS). The system accessories include sterile sheaths to fit various sizes of 4mm Olympus and Storz endoscopes, a sterile irrigation tubeset, and a non-sterile footpedal. The console includes software to control irrigation delivery and suction.

The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the general purpose ESG-400 workstation.

The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the general purpose ESG-400 workstation. The device is a single use, sterile accessory, to be used in conjunction with the bipolar outputs of the Olympus workstation with PK software (ESG-400). The proposed device is a modification of the Gyrus HALO PKS Cutting Forceps and includes an improved handle and improved jaw performance. The device handle has been redesigned with internal changes to improve ease of use. The jaws are identical as those found on the predicate Gyrus HALO PKS Cutting Forceps except that coatings have been added, and a mechanical bridge has been added inside the shaft.

The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

The PK Needle is a bipolar electrosurgical instrument with the capability to resect soft tissue and blood vessels in laparoscopic and general surgical procedures. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The device has an active blunt needle shaped tip and is activated via a button on the handle, or by a foot pedal. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator.