510(k) · Cleared
ClearedSharkcore Fine Needle Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · FCG Biopsy Needle
Cleared on Oct 6, 2014 as substantially equivalent to K133008 (Beacon Endoscopic, 2013) and 1 other predicate after an 84-day review. Its family tree reaches back 7 generations to 1995. 4 later devices descend from it.
- Decided
- Oct 6, 2014
- Review
- 84 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935844 (1995). 14 ancestors in all, the oldest K904667 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 6 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 5 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 4 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 3 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 2 generations backK103668 BNX Fine Needle Aspiration SystemBoston Endoscopic Engineering · 2010 · Recalled
- 1 generation backK133008 BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19…Beacon Endoscopic · 2013
- This deviceK141894 Sharkcore Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2014
- Descendant · cites it directly · 3 of its ownK150891 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle…Covidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015
- Descendant · 2 generations on · 1 of its ownK163058 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
- Descendant · 3 generations on · 0 of its ownK173184 Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017
- Descendant · 2 generations on · 0 of its ownK152586 Beacon Fine Needle Fiducial SystemCovidien, LLC · 2015
Most influential descendants
Showing 4 of 4 · See all- K150891BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy SystemCovidien, LLC ( Formerly Beacon Endoscopic Corp.) · 2015 · cites it directly3descendants
- K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017 · 2 generations on1descendant
- K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific · 2017 · 3 generations on0descendants
- K152586Beacon Fine Needle Fiducial SystemCovidien, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −6 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −5 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −4 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −3 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −2 | K103668 | BNX Fine Needle Aspiration System | Boston Endoscopic Engineering | 2010 | 5 |
| −1 | K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25… | Beacon Endoscopic | 2013 | — |
| 0 (this device) | 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 | — |
| +2 | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
| +3 | K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | Boston Scientific | 2017 | — |
| +2 | K152586 | Beacon Fine Needle Fiducial System | Covidien, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 2 | 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 FCG? 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K133008 | BNX Delivery System Pre-Loaded with 19, 22 and 25 Gauge Needle, 19, 22 or 25 Gauge…Summary page 5…ber, Owner/Operator Number: Establishment Registration Number: 3009144059 Owner/Operator Number: 10037745 Predicate Devices BNX Fine Needle Aspiration System (reference K133008, November 20, 2013) EchoTip Ultra Ultrasound Needle (reference K083330; Feb 06, 2009) Device Description The SharkCore™ Fine Nee… | 2013 |
| * | K083330 | Echotip Ultra Ultrasound NeedleSummary page 5…59 Owner/Operator Number: 10037745 Predicate Devices BNX Fine Needle Aspiration System (reference K133008, November 20, 2013) EchoTip Ultra Ultrasound Needle (reference K083330; Feb 06, 2009) Device Description The SharkCore™ Fine Needle Biopsy (FNB) System is an echogenic biopsy needle used through the… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150891 | BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System | 2015 | 3 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K150891 (Covidien, LLC ( Formerly Beacon Endoscopic Corp.), 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K133008.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SharkCore™ Fine Needle Biopsy System is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.
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/K141894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141894: Sharkcore Fine Needle Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141894
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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