510(k) · Cleared
ClearedGibbons Sterile Trocar Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gibbons Surgical Corp. · FBQ Trocar, Gastro-Urology
Cleared on Aug 9, 2001 after a 27-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 18 later devices descend from it.
- Decided
- Aug 9, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- FBQ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK012198 Gibbons Sterile Trocar KitsGibbons Surgical Corp. · 2001
- Descendant · cites it directly · 17 of its ownK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 14 of its ownK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
- Descendant · 3 generations on · 5 of its ownK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK142611 TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · cites it directly17descendants
- K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013 · 2 generations on14descendants
- K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013 · 2 generations on6descendants
- K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013 · 3 generations on5descendants
- K142611TYRX Neuro Absorbable Antibacterial EnvelopeMedtronic Tyrx, Inc. · 2014 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012198 | Gibbons Sterile Trocar Kits | Gibbons Surgical Corp. | 2001 | — |
| +1 | K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | Tyrx Pharma, Inc. | 2008 | 3 |
| +2 | K130943 | Aigis RX R PM/ Aigis RX R Icd | Tyrx, Inc. | 2013 | — |
| +2 | K131007 | Aigis RX N Medium; Aigis RX N Large | Tyrx, Inc. | 2013 | — |
| +3 | K132699 | Aigis RX N (Medium), Aigis RX N (Large) | Tyrx, Inc. | 2013 | — |
| +3 | K142611 | TYRX Neuro Absorbable Antibacterial Envelope | Medtronic Tyrx, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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 FBQ? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063091 | Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 | 2008 | 17 |
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, K063091 (Tyrx Pharma, Inc., 2008) has gone furthest, with 17 descendants of its own.
How does its category compare?
All FBQ devicesFBQ Trocar, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FBQ
FDA has decided no FBQ device since 2007.
Median 510(k) review, days · FBQ
Too few FBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · FBQ
No recall names FBQ since 2007.
Adverse event reports per year · FBQ
1in 2025
MAUDE reports naming product code FBQ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/endoscopic surgery under the guidance of a physician.
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/K012198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012198: Gibbons Sterile Trocar Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012198
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026