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510(k) K121337

UROPLASTY RIGID ENDOSCPIC NEEDLES by Uroplasty, Inc. — Product Code FBK

K121337 is an FDA 510(k) premarket notification submitted by Uroplasty, Inc. for the device "UROPLASTY RIGID ENDOSCPIC NEEDLES". The FDA issued a decision of Substantially Equivalent on August 3, 2012. 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 3, 2012
Date Received
May 3, 2012
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.

  • 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)
  • K051905 — UROPLASTY RIGID ENDOSCOPIC NEEDLE (August 29, 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