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510(k) K935480

MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS by Evans Medical, Inc. — Product Code FMI

K935480 is an FDA 510(k) premarket notification submitted by Evans Medical, Inc. for the device "MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS". The FDA issued a decision of Substantially Equivalent on January 28, 1994. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Evans Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
October 25, 1993
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 Evans Medical, Inc.

  • K020530 — EVANS SUB-Q, MODEL MC4206 (April 29, 2002)
  • K935641 — 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS (January 28, 1994)
  • K935642 — EVANS MEDICAL EXTENSION SETS (January 28, 1994)

Other clearances for product code FMI

  • K261266 — MOWANA™ Auto Duo (September 17, 2026)
  • K261719 — Promisemed X-Safety Pen Needle (August 25, 2026)
  • 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)

FDA data resources