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510(k) K953441

RIZA-RIBE NEEDLE by R-Med, Inc. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1995
Date Received
July 17, 1995
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 R-Med, Inc.

  • K001236 — RIZA BAND STRETCHER (RBS)-60000 (July 17, 2000)
  • K953360 — R-MED ABDOMINAL WALL ELEVATOR (January 11, 1996)
  • K954882 — RIZA-RIBE NEEDLE (MODIFICATION) (November 16, 1995)
  • K950108 — R-MED MINI-RETRACTOR (May 11, 1995)
  • K942411 — R-MED DISPOSABLE PLUG (March 31, 1995)
  • K945637 — R-MED MOTORIZED LAPAROSCOPIC HANDLE (December 7, 1994)
  • K943818 — MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS (August 29, 1994)
  • K935031 — RIZA-RIBE NEEDLE (April 25, 1994)

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  • 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)
  • K230925 — Disposable Injection Needle AF series (September 27, 2023)
  • K222006 — Sclerotherapy & Endoscopic Needles (April 3, 2023)