510(k) · Cleared
ClearedSabre BT BLUNT0TIP Surgical Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endoscopic Concepts, Inc. · FBQ Trocar, Gastro-Urology
Cleared on Apr 1, 1998 as substantially equivalent to K943976 (Endoscopic Concepts, Inc., 1994) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Apr 1, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- FBQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933456 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK933456 Comed Trogard (TM) Blunt Tip Trocar/SleeveConmedcorp · 1993
- This deviceK980804 Sabre BT BLUNT0TIP Surgical TrocarEndoscopic Concepts, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933456 | Comed Trogard (TM) Blunt Tip Trocar/Sleeve | Conmedcorp | 1993 | — |
| 0 (this device) | K980804 | Sabre BT BLUNT0TIP Surgical Trocar | Endoscopic Concepts, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 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? (2)
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 |
|---|---|---|---|
| * | K943976 | Sabre Ultimate Shielded TrocarSummary page 1…Trocar System Manufactured and Distributed by: Manufactured and Distributed by: Endoscopic Concepts Inc. ConMed™ Aspen Surgical Systems Mendon, MA 01756 Utica, NY 13501 K943976 K933456 Product Description: The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smoo… | 1994 |
| * | K933456 | Comed Trogard (TM) Blunt Tip Trocar/SleeveSummary page 1…System Manufactured and Distributed by: Manufactured and Distributed by: Endoscopic Concepts Inc. ConMed™ Aspen Surgical Systems Mendon, MA 01756 Utica, NY 13501 K943976 K933456 Product Description: The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smooth (non… | 1993 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K943976.
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 ECI Sabre BT™ Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and to permit maintenance of insufflation.
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/K980804 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980804: Sabre BT BLUNT0TIP Surgical Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980804
Report an extraction error
Are you the manufacturer?
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