Home / 510(k) Clearances / K980062

510(k) K980062

MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE by Davis & Geck, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1998
Date Received
January 7, 1998
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 Davis & Geck, Inc.

  • K982853 — SILK SUTURE (April 30, 1999)
  • K981582 — SURGILON, DERMALON, & OPHTHALON (July 13, 1998)
  • K980610 — DEXON RAPID (DEXON R) (May 18, 1998)
  • K974015 — ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QU (May 18, 1998)
  • K973409 — KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS (February 27, 1998)
  • K970857 — ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL AR (November 5, 1997)
  • K972139 — ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOP (September 3, 1997)
  • K972566 — DEXON VIOLET (August 14, 1997)
  • K962971 — POLYPROPYLENE MESH (VARIOUS SIZES) (September 16, 1996)
  • K955722 — FLEXON TEMPORARY CARDIAC PACER LEAD (March 15, 1996)

Other clearances for product code FMI

  • K252886 — Pen Needle (January 6, 2026)
  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K252631 — Profoject™ Disposable Needle (October 16, 2025)
  • K250724 — Intraosseous Infusion Needles (July 30, 2025)
  • K250284 — TSK SELECT™ Needle (July 24, 2025)
  • K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (July 8, 2025)
  • K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) (May 29, 2025)
  • K240355 — FROG (Filter Removal of Glass) (April 18, 2025)
  • K243581 — K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) (April 4, 2025)
  • K250658 — SureFine Pen Needle (April 3, 2025)