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510(k) K864407

REFILLABLE SYRINGE by Med Fusion Systems, Inc. — Product Code FMF

K864407 is an FDA 510(k) premarket notification submitted by Med Fusion Systems, Inc. for the device "REFILLABLE SYRINGE". The FDA issued a decision of Substantially Equivalent on January 20, 1987. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Med Fusion Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
November 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Med Fusion Systems, Inc.

  • K873961 — INFUMED 300 AMBULATORY INFUSION PUMP (December 29, 1987)
  • K870524 — AMBULATORY INFUSION PUMP DRUG RESERVOIR (May 6, 1987)
  • K870907 — INTRODUCER, PERCUTANEOUS (April 9, 1987)
  • K863814 — BAG SPIKE EXTENSION SET (October 14, 1986)
  • K860616 — VOLUME CONTROL SET WITH EXTENSION (June 2, 1986)
  • K860803 — IV FILTER EXTENSION SET (April 9, 1986)
  • K844313 — INFUSET W/HUBER NEEDLE (January 22, 1985)
  • K842984 — EXTENSION SET W/INJECTION SITE (October 16, 1984)
  • K842143 — BENT WINGED MINI-VOL INFUSION SET (July 20, 1984)
  • K841882 — THREE WAY INFUSION SET (June 5, 1984)

Other clearances for product code FMF

  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); (May 21, 2026)
  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)

FDA data resources