510(k) · Cleared
Recalled · 2011Auto Suture Kerrison Spinal Rongeur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · HAE Rongeur, Manual
Cleared on Jul 27, 1994 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Jul 27, 1994
- Review
- 30 days
- Class
- Class II
- Product code
- HAE
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, 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 HAE? 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 HAE device
- #1 K260446 Tontarra Punches and Rongeursscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, 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 |
|---|---|---|---|---|
| May 25, 2011 | Not classified | Z-2832-2011 | Labeling False and Misleading | Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT"… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAE
270in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAE
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAE
10in 2025
MAUDE reports naming product code HAE, 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 | 2 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 2 | — | 0 | 47 |
| 2013 | 2 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 4 | 270 | 0 | 34 |
| 2017 | 0 | — | 0 | 25 |
| 2018 | 1 | — | 0 | 29 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 13 |
| 2023 | 2 | — | 2 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K943116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943116: Auto Suture Kerrison Spinal Rongeur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943116
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026