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510(k) K010958

FISTULOK FISTULA NEEDLE PROTECTION by Diasol, Inc. — Product Code FMI

K010958 is an FDA 510(k) premarket notification submitted by Diasol, Inc. for the device "FISTULOK FISTULA NEEDLE PROTECTION". The FDA issued a decision of Substantially Equivalent on May 18, 2001. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Diasol, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2001
Date Received
March 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Diasol, Inc.

  • K130511 — CITRISOL ACID CONCENTRATE (February 10, 2014)
  • K020231 — DIASOL-ADDITIVES (October 21, 2002)
  • K020230 — DIASOL-BICARB (April 23, 2002)
  • K011004 — NEEDLELOK HYPODERMIC NEEDLE PROTECTION (May 24, 2001)
  • K011003 — SAFESTING AND SAFESTING HUB (April 20, 2001)
  • K992999 — DAISY PROTECTED SCALP VEIN SET (November 5, 1999)
  • K993187 — SHELLY PROTECTED AV FISTULA NEEDLE (November 5, 1999)
  • K992653 — SHELLY PROTECTED AV FISTULA NEEDLE (October 27, 1999)
  • K993212 — DRYASOL ACID CONCENTRATE MIX (October 22, 1999)

Other clearances for product code FMI

  • K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, (August 10, 2026)
  • K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, N (August 7, 2026)
  • K261829 — Profoject™ Dual-Safety Pen Needles (July 29, 2026)
  • K260739 — Profoject™ Pen Needles (Model A; Model B) (July 15, 2026)
  • K260855 — Profoject™ Safety Pen Needles (June 10, 2026)
  • K254273 — Verisafe Safety Sterile Needles (SSN) (April 16, 2026)
  • K252908 — Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen (March 25, 2026)
  • K253047 — PRESSONE™ (March 24, 2026)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • K252886 — Pen Needle (January 6, 2026)

FDA data resources