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Endoscopic ultrasound devices

SharkCore™ FNB needle

<p>The SharkCore™ fine needle biopsy (FNB) system is used with an ultrasound endoscope for needle biopsy of submucosal lesions, mediastinal masses, and more.</p>

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Features

Power in every puncture

The SharkCore™ FNB needle provides superior puncture force compared to a Franseen needle design.‡,12–15 The distal cutting design minimizes tissue damage as it’s collected, enhancing tissue acquisition and diagnostic yield.1,4,9–11,16

Reshape the diagnostic journey.

Ordering information

Item number Product description Units per box
DSL-19-01 SharkCore™ fine needle biopsy system with preloaded needle — 19-gauge 1
DSC-22-01 SharkCore™ fine needle biopsy system with preloaded needle — 22-gauge 1
DSC-25-01 SharkCore™ fine needle biopsy system with preloaded needle — 25-gauge 1
L-19-05 SharkCore™ FNB individually packed needles — 19-gauge 5
C-22-05 SharkCore™ FNB individually packed needles — 22-gauge 5
C-25-05 SharkCore™ FNB individually packed needles — 25-gauge 5

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† Compared to FNA needle tips by decreasing penetration force.

‡ Bench test data may not be indicative of clinical performance.

  1. Based on internal Beacon™ Endosopic report. REP-1085 (01) BNX EUS FNB Design Review. 2014.
  2. Based on internal Beacon™ Endosopic report. REP-1090 (01) BNX EUS FNB Design Verification Review. 2014.
  3. Adler DG, Witt B, Chadwick B, Wells J, Taylor LJ, Dimaio C, Schmidt R. Pathologic evaluation of a new endoscopic ultrasound needle designed to obtain core tissue samples: A pilot study. Endosc Ultrasound. 2016 May–Jun;5(3):178–183.
  4. DiMaio CJ., et al. Initial Experience with a novel EUS-guided core biopsy needle (SharkCore™): results of a large North American multicenter study. Endosc Int Open. 2016 Sep;4(9): E974–E979.
  5. Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6);1432–1438.
  6. Kandel P, Tranesh G, Nassar A, Bingham R, Raimondo M, Woodward TA, Gomez V, Wallace MB. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc. 2016 Dec;84(6):1034–1039.
  7. Jovani M, Abidi WM, Lee LS. Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study. Scand J Gastroenterol. 2017;52(6-7):784–787. 
  8. Rodrigues-Pinto E, Jalaj S, Grimm IS, Baron TH. Impact of EUS-guided fine-needle biopsy sampling with a new core needle on the need for onsite cytopathologic assessment: a preliminary study. Gastrointest Endosc. 2016;84(6):1040–1046. 
  9. Moore JZ, McLaughlin PW, Shih AJ. Novel needle cutting edge geometry for end-cut biopsy. Med Phys. 2012;39(1):99–108. 
  10. Based on internal Covidien verification report. TR-20011 (1) SharkCore Design 2014.
  11. Based on internal Covidien report. TR-20007 (1) EUS FNB Core Needle Comparative Test. 2014.

  1. Based on internal report RE00514376 Rev. A, SharkCore™ and Acquire™* Franseen needle tip puncture force comparison protocol. June 2024.
  2. Based on internal report RE00514379 Rev. A, SharkCore™ and Acquire™* Franseen needle puncture force comparison. June 2024.
  3. Based on bench testing data comparing the puncture force of SharkCore™ FNB device and Franseen FNB. FNB SharkCore™ versus Franseen. May 2016. Data on file.
  4. Based on bench testing data comparing the puncture force of SharkCore™ FNB device and Franseen FNB. SharkCore™ versus Acquire Needle Puncture Force Comparison. Raw Instron Data 1. Data on file.
  5. MedVenture Technology Corp.. PN1006510 (B) Needle - FNB - 25. 2015.