# K963653: Wallach Quantum 2000 Electrosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Jun 11, 1997 after 272 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 29, 2021 · Class II · Z-0259-2022: Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraopera
- Sep 29, 2021 · Class II · Z-0260-2022: Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraopera
- Sep 29, 2021 · Class II · Z-0262-2022: Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraopera
- Sep 29, 2021 · Class II · Z-0263-2022: XXX
- Sep 29, 2021 · Class II · Z-0261-2022: Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraopera
- Oct 16, 2019 · Class II · Z-0602-2020: Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for a
- Oct 16, 2019 · Class II · Z-0600-2020: Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for a
- Oct 16, 2019 · Class II · Z-0601-2020: Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for a
- Jun 18, 2019 · Class II · Z-2057-2019: The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.

## Indications for use
The intended use of the Quantum 2000 System is for in-office electrosurgical OB/GYN procedures. Some OB/GYN indications for applications include: 1) Cervical Conization. 2) Large Loop Excision of the Transformation Zone (LLETZ) in the diagnosis and treatment of some Cervical Intraepithelial Neoplasias (CIN) and Dysplasias. 3) External Anogenital Lesions. 4) Large Vaginal Intraepithelial Neoplastic (VAIN) Lesions.

Source page: https://510kreport.com/device/K963653
Methodology: https://510kreport.com/methodology