510(k) · Cleared
ClearedEndo-Tech LTD., Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ratio Design Lab · HFG Coagulator, Laparoscopic, Unipolar (And Accessories)
Cleared on Jul 1, 1996 after a 61-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 1, 1996
- Review
- 61 days
- Class
- Class II
- Product code
- HFG
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HFG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Electrosurgical Attachments sold by American Hydro-Surgical Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HFG devicesHFG Coagulator, Laparoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HFG
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HFG
Too few HFG 510(k)s in any year since 2007 to give a median.
Recalls per year · HFG
No recall names HFG since 2007.
Adverse event reports per year · HFG
32in 2025
MAUDE reports naming product code HFG, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Laparoscopic Unipolar Tips will serve as accessories to the Endo-Tech, Ltd, Inc.,Endo-Aid, which is an Aspiration- Irrigation Device. These tips will thread into the laparoscopic irrigation and aspiration control handle. The tips will be used during laparoscopic procedures and electrosurgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961695: Endo-Tech LTD., Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961695
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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