510(k) · Cleared
ClearedExpect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Jan 30, 2017 as substantially equivalent to K133312 (Boston Scientific Corporation, 2014) and 2 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Jan 30, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K935844 (1995). 31 ancestors in all, the oldest K904667 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 5 generations between
- 3 generations backK133008 BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19…Beacon Endoscopic · 2013
- 2 generations backK141894 Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2014
- 1 generation backK150891 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle…Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
- This deviceK163058 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
- Descendant · cites it directly · 0 of its ownK173184 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
Show all 9 generations
- Root · 9 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 8 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 7 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 6 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 5 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 4 generations backK103668 BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering · 2010 · Recalled
- 3 generations backK133008 BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19…Beacon Endoscopic · 2013
- 2 generations backK141894 Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2014
- 1 generation backK150891 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle…Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
- This deviceK163058 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
Most influential descendants
Showing 1 of 1 · See all- K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −8 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −7 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −6 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −5 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −4 | K103668 | BNX Fine Needle Aspiration System | Boston Endoscopic Engineering | 2010 | 5 |
| −3 | K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25… | Beacon Endoscopic | 2013 | — |
| −2 | K141894 | Sharkcore Fine Needle Biopsy System | Covidien, LLC ( Formerly Beacon Endoscopic Corp.) | 2014 | — |
| −1 | K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | Covidien, LLC ( Formerly Beacon Endoscopic Corp.) | 2015 | — |
| 0 (this device) | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
| +1 | K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 ODG? 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 ODG device
- #1 K251859 EVIS EUS Ultrasound Gastrointestinal…score 14.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K133312 | Expect Slimline Endoscopic Ultrasound Aspiration NeedleSummary page 4…876.1075 Product Code: ODG & FCG Classification: Class II 3. Predicate Device: Trade Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle 510(k) Number: K133312 Classification Name: Endoscopic Ultrasound System, Gastroenetrology-Urology and Biopsy Needle Regulation Number: 876.1500 & 876.1… | 2014 |
| * | K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19ASummary page 4…gulation Number: 876.1500 & 876.1075 Product Code: ODG & FCG Classification: Class II Trade Name: ECHO Tip Ultra High Definition Ultrasound Access Needle 510(k) Number: K092359 Classification Name: Biopsy Needle Regulation Number: 876.1075 Product Code: FCG Classification: Class II Trade Name: BNX Fine N… | 2009 |
| * | K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemSummary page 4…9 Classification Name: Biopsy Needle Regulation Number: 876.1075 Product Code: FCG Classification: Class II Trade Name: BNX Fine Needle Aspiration System 510(k) Number: K150891 Classification Name: Biopsy Needle and Marker, Radiographic, Implantable Regulation Number: 876.1075 & 878.4300 Product Code: FCG… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | 2017 | 0 |
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?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 31 ancestors have a recall of any class.
- Of its descendants, K173184 (Boston Scientific, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K133312.
How does its category compare?
All ODG devicesODG Endoscopic Ultrasound System, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · ODG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODG
71in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODG
4in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODG
3,569in 2025
MAUDE reports naming product code ODG, 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 | 1 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 1 | — | 0 | 50 |
| 2017 | 4 | 75 | 0 | 82 |
| 2018 | 3 | 30 | 0 | 66 |
| 2019 | 1 | — | 0 | 96 |
| 2020 | 2 | — | 4 | 445 |
| 2021 | 1 | — | 0 | 1,234 |
| 2022 | 4 | 71 | 0 | 1,832 |
| 2023 | 1 | — | 0 | 2,078 |
| 2024 | 1 | — | 0 | 1,904 |
| 2025 | 2 | — | 0 | 3,569 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163058: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163058
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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