# K111202: Surgical Tissue Management System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Jan 20, 2012 after 266 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K932293 (1994). 62 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050885: Olympus Ultrasonic Surgical System Sonosurg, Olympus Medical Systems Corporation (2005) Summary page 2.
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 2.
- K051644: Valleylab Forcetriad Electrosurgical Generator, Valleylab (2005) Summary page 2.
- K070162: Forcetriad Electrosurgical Generator; Ligasure Instruments, Valleylab,A Division of Tyco Healthcare Group LP (2007) Summary page 2.
- K043008: Surgrx Enseal Vessel Sealing & Hemostasis System, Surgrx, Inc. (2004) Summary page 2.
- K021962: Olympus Ultrasonic Surgical System, The Olympus Optical Co. (2003) Summary page 2.
- K031305: Olympus Ultrasonic Surgical System, Olympus Optical Co., Ltd. (2003) Summary page 2.
- K031523: Olympus Ultrasonic Surgical System, Aomori Olympus Co., Ltd. (2003) Summary page 2.
- K031710: Olympus Ultrasonic Surgical System, Aomori Olympus Co., Ltd. (2003) Summary page 2.
- K990430: Ultracision Harmonic Scalpel Hand Piece, Ethicon Endo-Surgery, Inc. (1999) Summary page 2.
- K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500, Valleylab, Inc. (2003) Summary page 5.
- K051036: Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36P, Ethicon Endo-Surgery, Inc. (2005) Summary page 6.
- K081129: Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal, Surgrx, Inc. (2008) Summary page 5.
- K031133: Surgrx Enseal Vessel Sealing and Hemostasis System Including the Enseal Controller Adapter, Enseal Open and Laparoscopis, Surgrx, Inc. (2003) Summary page 2.

## Most influential descendants
- K132703: Thunderbeat (2014), 9 descendants of its own
- K151743: THUNDERBEAT Open Fine Jaw (2016), 6 descendants of its own
- K192103: Thunderbeat Open Fine Jaw Type X Hand Instrument (2020), 4 descendants of its own
- K172610: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S,  THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (2018), 4 descendants of its own
- K172691: Ultrasonic Generator (2017), 4 descendants of its own

## Recalls of this device
- Oct 22, 2025 · Class II · Z-1381-2026: Firm is initiating a removal due to continued reports of adverse events.
- Oct 22, 2025 · Class II · Z-1375-2026: Firm is initiating a removal due to continued reports of adverse events.
- Oct 22, 2025 · Class II · Z-1382-2026: Firm is initiating a removal due to continued reports of adverse events.
- Oct 22, 2025 · Class II · Z-1380-2026: Firm is initiating a removal due to continued reports of adverse events.
- Oct 22, 2025 · Class II · Z-1378-2026: Firm is initiating a removal due to continued reports of adverse events.
- Oct 22, 2025 · Class II · Z-1377-2026: Firm is initiating a removal due to continued reports of adverse events.
- Oct 22, 2025 · Class II · Z-1374-2026: Firm is initiating a removal due to continued reports of adverse events.
- Oct 22, 2025 · Class II · Z-1376-2026: Firm is initiating a removal due to continued reports of adverse events.
- Oct 22, 2025 · Class II · Z-1379-2026: Firm is initiating a removal due to continued reports of adverse events.
- Sep 27, 2013 · Class II · Z-0432-2014: Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.

## Indications for use
The Surgical Tissue Management System is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-5B400), the THUNDERBEAT, and / or the SONICBEAT for open, laparoscopic (including single-site surgery), and endloscopic surgery to cut (dissbct) or coagulate soft tissue or to ligate (seat and cut) vessels. The Surgical Tissue Management System has three output modes, Seal & Cut (THUNOERBEAT), Seal (THUNDERBEAT) and Ultrasonic (SONICBEAT). The Seal & Cut mode provides combined HF bipolar and ultrasonic energy, the seal mode provides only HF bipolar energy and the Ultrasonic mode provides only ultrasonic energy. This system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. The Ultrasonic Generator (USG-400) is intended to be used with the Electrosurgical Generator (ESG-400), the THUNDERBEAT Transducer (TD-TB400), the SONICBEAT Transducer (TD-SB400), the THUNDERBEAT, and / or the SONIOBEAT for open, laparoscopic (including single-site surgery), and endloscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment. The THUNDERBEAT Transducer (TD-TB400) is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. The THUNDERBEAT hand instruments are intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (ESG-400), and the THUNDERBEAT Transducer, (TO-TB400). Seal & Cut mode: The THUNDERBEAT hand instruments when used in combination with the Seal & Cut mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed. These devices have been designed to seal and cut vessels up to and including 7mm in diameter. Seal mode: The THUNDERBEAT hand instruments when used in combination with the Seal mode are indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc), and endoscopic surgery or in any procedure in which vessel sealing, coagulation, grasping is performed. These devices have been designed to seal vessels up to and including 7mm in diameter. The THUNDERBEAT hand instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures. The SONIOBEAT Transducer (TD-SB400) is intended to be used with the Ultrasonic Generator (USG-400) and the SONICBEAT for open, laparoscopic (including single-site surgery), and endloscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. The SONICBEAT is intended to be used with the Ultrasonic Generator (USG-400) and the SONIOBEAT Transducer (TD-SB4QO) for open, laparoscopic (including single-site surgery), and general surgery to cut (dissect), coagulate, or grasp soft tissue or to ligate (seal and cut) vessels in gynecologic, thoracic, urologic, and endoscopic surgical procedures. These devices have been designed to seal and cut vessels up to and including 5mm in diameter. The SONIOBEAT has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Source page: https://510kreport.com/device/K111202
Methodology: https://510kreport.com/methodology