510(k) · Cleared
Recalled · Class II · 2021Wallach Integration Unit
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 Mar 19, 1997 after a 205-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 4 times.
- Decided
- Mar 19, 1997
- Review
- 205 days
- Class
- Class II
- Product code
- HGI
- Recalls
- 4
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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-0257-2022 | 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-0258-2022 | 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. |
| 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. |
| Apr 23, 2019 | Class II | Z-1840-2019 | Process control | 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses. |
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 | — |
https://510kreport.com/device/K963348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963348: Wallach Integration Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963348
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026