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FDA 510(k)

NEBULAE SRS Laparoscopic Surgical Smoke Removal System

K-Number: K202944 · 2021-03-25

ApplicantNorthgate Technologies, Inc.
Decision Date2021-03-25
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEBULAE SRS Laparoscopic Surgical Smoke Removal System is a medical device manufactured by Northgate Technologies, Inc.. It received FDA 510(k) clearance on 2021-03-25 under approval number K202944. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEBULAE SRS Laparoscopic Surgical Smoke Removal System?

NEBULAE SRS Laparoscopic Surgical Smoke Removal System is a medical device that received FDA 510(k) clearance on 2021-03-25. It is manufactured by Northgate Technologies, Inc.. The 510(k) number is K202944.

When was NEBULAE SRS Laparoscopic Surgical Smoke Removal System approved by the FDA?

NEBULAE SRS Laparoscopic Surgical Smoke Removal System received FDA 510(k) clearance on 2021-03-25, under approval number K202944.

What company makes NEBULAE SRS Laparoscopic Surgical Smoke Removal System?

NEBULAE SRS Laparoscopic Surgical Smoke Removal System is manufactured by Northgate Technologies, Inc..

What is the FDA product code for NEBULAE SRS Laparoscopic Surgical Smoke Removal System?

The FDA product code for NEBULAE SRS Laparoscopic Surgical Smoke Removal System is FYD.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07202312 Ozone-therapy in Non-surgical Periodontal Therapy COMPLETED NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40902105 Design of Automatic Tool Replacement Mechanism for Laparoscopic Surgical Robot Arm for Solo Surgery. The international journal of medical robotics + computer assisted surgery : MRCAS (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Northgate Technologies, Inc.

K202813URO-TOUCH 9 French Probe

Related Devices (Code: FYD)

K163659Crystal VisionI.C Medical, Inc. K173108SmokleanSejong Medical Co., Ltd. K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc. K191328Megadyne Foot SwitchMegadyne Medical Products, Inc. K182224SafeAir Smoke Evacuator compactLina Medical Aps K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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