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510(k) K983765

INJECTION NEEDLE PROBE/DEVICE-TUNIS by Ximed/Prosure/Injectx — Product Code FBK

K983765 is an FDA 510(k) premarket notification submitted by Ximed/Prosure/Injectx for the device "INJECTION NEEDLE PROBE/DEVICE-TUNIS". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Ximed/Prosure/Injectx has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
October 26, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

Other clearances by Ximed/Prosure/Injectx

  • K002269 — ELECTROSURGICAL PROBES AND DEVICES-GELTX (January 4, 2001)
  • K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (March 1, 2000)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE (May 12, 1998)
  • K974484 — ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE (February 10, 1998)
  • K974637 — ELECTRODES/PROBES/DEVICES (January 7, 1998)
  • K962593 — ELECTROSURGICAL PROBES & DEVICES (November 12, 1996)
  • K945995 — BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS (January 31, 1995)

Other clearances for product code FBK

  • K260262 — Injection Needle (May 29, 2026)
  • K253598 — InjecSURE Injection System (March 31, 2026)
  • K252021 — Disposable Endoscopic Injection Needles (December 2, 2025)
  • K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use (October 16, 2025)
  • K241595 — EzVu Visual Vasopressor injector (EV-19) (February 27, 2025)
  • K240675 — Endoscopic Injection Needles (October 4, 2024)
  • K241523 — injeTAK Adjustable Tip Needle (DIS199; DIS201) (August 27, 2024)
  • K232200 — Disposable Injection Needles (April 12, 2024)
  • K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810) (March 8, 2024)
  • K232442 — Disposable Endoscope Injection Needles (November 9, 2023)

FDA data resources