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510(k) K061492

MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE by Tyco Healthcare — Product Code FMF

K061492 is an FDA 510(k) premarket notification submitted by Tyco Healthcare for the device "MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE". The FDA issued a decision of Substantially Equivalent on August 3, 2006. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Tyco Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2006
Date Received
May 31, 2006
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 Tyco Healthcare

  • K071049 — DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR (October 16, 2007)
  • K070685 — KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 (September 14, 2007)
  • K070653 — KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 (September 12, 2007)
  • K042709 — DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER (January 18, 2005)
  • K040897 — DOVER ROB-NEL CATHETER (July 20, 2004)
  • K040649 — KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE (July 15, 2004)
  • K041243 — DOVER RED RUBBER ROBINSON CATHETER (July 7, 2004)
  • K032438 — MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PRE (June 30, 2004)
  • K033453 — KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING (April 29, 2004)
  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)

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