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510(k) K051905

UROPLASTY RIGID ENDOSCOPIC NEEDLE by Uroplasty, Inc. — Product Code FBK

K051905 is an FDA 510(k) premarket notification submitted by Uroplasty, Inc. for the device "UROPLASTY RIGID ENDOSCOPIC NEEDLE". The FDA issued a decision of Substantially Equivalent on August 29, 2005. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Uroplasty, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2005
Date Received
July 14, 2005
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 Uroplasty, Inc.

  • K121337 — UROPLASTY RIGID ENDOSCPIC NEEDLES (August 3, 2012)
  • K101847 — URGENT PC STIMULATOR; URGENT PC LEAD SET (October 21, 2010)
  • K091391 — UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 (June 30, 2009)
  • K071822 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 (August 20, 2007)
  • K061333 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 (July 3, 2006)
  • K052175 — I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 (October 17, 2005)
  • K052025 — URGENT PC NEUROMODULATION SYSTEM (October 17, 2005)

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