510(k) · Cleared
ClearedInsufflation Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Sep 24, 1996 after a 29-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Sep 24, 1996
- Review
- 29 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK963359 Insufflation NeedleApplied Medical Resources · 1996
- Descendant · cites it directly · 2 of its ownK041795 Modification to Optical Separator SystemApplied Medical Resources Corp. · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK111002 Reprocessed Endoscopic TrocarsSterilmed, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK063788 Reprocessed Endoscopic Trocars and CannulasAscent Healthcare Solutions · 2007 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K041795Modification to Optical Separator SystemApplied Medical Resources Corp. · 2004 · cites it directly2descendants
- K111002Reprocessed Endoscopic TrocarsSterilmed, Inc. · 2011 · 2 generations on0descendants
- K063788Reprocessed Endoscopic Trocars and CannulasAscent Healthcare Solutions · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963359 | Insufflation Needle | Applied Medical Resources | 1996 | — |
| +1 | K041795 | Modification to Optical Separator System | Applied Medical Resources Corp. | 2004 | 1 |
| +2 | K111002 | Reprocessed Endoscopic Trocars | Sterilmed, Inc. | 2011 | — |
| +2 | K063788 | Reprocessed Endoscopic Trocars and Cannulas | Ascent Healthcare Solutions | 2007 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
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 HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041795 | Modification to Optical Separator System | 2004 | 2 |
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.
What does this lineage say?
- Of its descendants, K041795 (Applied Medical Resources Corp., 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMR Insufflation Needle is a disposable device indicated for use for insufflating the peritoneum prior to laparoscopic surgery.
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/K963359 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963359: Insufflation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963359
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026