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510(k) K953441

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

K953441 is an FDA 510(k) premarket notification submitted by R-Med, Inc. for the device "RIZA-RIBE NEEDLE". The FDA issued a decision of Substantially Equivalent on August 18, 1995. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. R-Med, Inc. has at least 8 other 510(k) clearances on record.

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)

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