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510(k) K914496

SCLEROTHERAPY NEEDLE by Surgitek Medical Engineering Corp. — Product Code FBK

K914496 is an FDA 510(k) premarket notification submitted by Surgitek Medical Engineering Corp. for the device "SCLEROTHERAPY NEEDLE". The FDA issued a decision of Substantially Equivalent on December 5, 1991. The device falls under product code FBK (Endoscopic Injection Needle, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Surgitek Medical Engineering Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1991
Date Received
October 8, 1991
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 Surgitek Medical Engineering Corp.

  • K914504 — CYTOLOGY BRUSH (February 18, 1992)
  • K914495 — E.R.C.P. CATHETER (January 30, 1992)
  • K914497 — BIOPSY FORCEPS (January 3, 1992)
  • K914505 — STONE BASKET (December 9, 1991)
  • K914503 — GRASPING FORCEPS (December 5, 1991)
  • K913928 — SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT (November 19, 1991)
  • K913294 — SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT (October 4, 1991)
  • K910769 — SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM (June 25, 1991)
  • K910768 — SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE (March 19, 1991)
  • K903127 — SURGITEK(R) TURP MONITOR (October 9, 1990)

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