510(k) · Cleared
Recalled · Class II · 2021Wallach Quantum 2000 Electrosurgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallach Surgical Devices, Inc. · HGI Electrocautery, Gynecologic (And Accessories)
Cleared on Jun 11, 1997 after a 272-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 9 times.
- Decided
- Jun 11, 1997
- Review
- 272 days
- Class
- Class II
- Product code
- HGI
- Recalls
- 9
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HGI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HGI device
- #1 K202915 IRIS Thermocoagulator and Digital Colposcopescore 2.1 · 4 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2021 | Class II | Z-0259-2022 | Component design/selection | 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 intraoperative bleeding and complete the case. |
| Sep 29, 2021 | Class II | Z-0260-2022 | Component design/selection | 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 intraoperative bleeding and complete the case. |
| Sep 29, 2021 | Class II | Z-0262-2022 | Component design/selection | 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 intraoperative bleeding and complete the case. |
| Sep 29, 2021 | Class II | Z-0263-2022 | Component design/selection | XXX |
| Sep 29, 2021 | Class II | Z-0261-2022 | Component design/selection | 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 intraoperative bleeding and complete the case. |
| Oct 16, 2019 | Class II | Z-0602-2020 | Device Design | 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 activation. |
| Oct 16, 2019 | Class II | Z-0600-2020 | Device Design | 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 activation. |
| Oct 16, 2019 | Class II | Z-0601-2020 | Device Design | 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 activation. |
| Jun 18, 2019 | Class II | Z-2057-2019 | Device Design | The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HGI devicesHGI Electrocautery, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGI
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · HGI
Too few HGI 510(k)s in any year since 2007 to give a median.
Recalls per year · HGI
7in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGI
41in 2025
MAUDE reports naming product code HGI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 1 | — | 0 | 56 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 30 |
| 2019 | 0 | — | 3 | 127 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 1 | — | 7 | 100 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963653: Wallach Quantum 2000 Electrosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963653
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026