Siss, Inc. (D.b.a.medisiss) Reprocessd Electrosurgical Instruments and Accessories

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K030919 ↗

FDA Product Code

NLR

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Medisiss Reprocessed Arthroscopic Shavers and Burs

  Class II

  FDA 510(k) K113028 Active Cleared 20 Dec 2011

• Medisiss Reprocessed Ultrasonic Surgical Instruments

  Unclassified

  FDA 510(k) K030598 Active Cleared 23 Jan 2004

• Genesis

  Class II

  FDA 510(k) K081559 Active Cleared 28 Aug 2008

• Medisiss Reprocessed Non-Electric Gi Biopsy Forceps

  Class I

  FDA 510(k) K042659 Active Cleared 14 Feb 2005

• Medississ Reprocessedent Ablation Wands (Coblators), MODEL#EIC8872-01 Open recall

  Class II

  FDA 510(k) K100543 Active Cleared 23 Jul 2010

• What are the SISS Inc. Reprocessed Electrosurgical Instruments used for?

  These instruments are designed for minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and facilitating coagulation, transection, resection, mobilization, and dissection of tissue specifically in gastroenterology and urology procedures.

• How are these electrosurgical instruments supplied and can they be reused?

  The instruments are supplied as reprocessed devices and are intended for single use in surgical settings. They should not be reused as they are designed for one-time use only to ensure safety and effectiveness.

• What is the regulatory status of these electrosurgical instruments?

  The device has FDA 510(k) clearance with K number K030919 and is classified as a Class II medical device under product code NLR. This means it has been determined to be substantially equivalent to existing devices on the market.

• What specialties typically use these reprocessed electrosurgical instruments?

  These instruments are specifically intended for use in gastroenterology and urology procedures, as indicated by their review advisory committee designation and medical specialty description.