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510(k) K864747

VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES by Jms Co., Ltd. — Product Code FMF

K864747 is an FDA 510(k) premarket notification submitted by Jms Co., Ltd. for the device "VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES". The FDA issued a decision of Substantially Equivalent on December 29, 1986. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Jms Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1986
Date Received
December 5, 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 Jms Co., Ltd.

  • K002352 — JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE (September 6, 2001)
  • K002394 — JMS APHERESIS NEEDLE SET ACCORDION TYPE (September 5, 2001)
  • K010406 — JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G (June 20, 2001)
  • K010410 — JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G (June 20, 2001)
  • K000843 — MODIFICATION TO JMS APHERESIS NEEDLE (April 10, 2000)
  • K000845 — MODIFICATION TO JMS A.V. FISTULA NEEDLE SET (April 10, 2000)
  • K991904 — MODIFICATION OF JMS NEEDLES AND JMS SYRINGES (August 31, 1999)
  • K990470 — JMS A. V. FISTULA NEEDLE SET (August 30, 1999)
  • K990510 — JMS APHERESIS NEEDLE (August 30, 1999)
  • K983707 — JMS DIALYZER PRIMING SET (January 8, 1999)

Other clearances for product code FMF

  • K262581 — GraftGun Universal Graft Delivery System (GDS®) (August 26, 2026)
  • K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray (August 25, 2026)
  • K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03) (August 14, 2026)
  • 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)

FDA data resources