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510(k) K961328

BEC SHROUDED PLASTIC CANNULA by Biological & Environmental Control Laboratories — Product Code FMI

K961328 is an FDA 510(k) premarket notification submitted by Biological & Environmental Control Laboratories for the device "BEC SHROUDED PLASTIC CANNULA". The FDA issued a decision of Substantially Equivalent on May 30, 1996. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Biological & Environmental Control Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1996
Date Received
April 8, 1996
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 Biological & Environmental Control Laboratories

  • K971500 — ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER (August 18, 1997)
  • K962802 — SAFE MATE I.V. FLUID DELIVERY SETS (August 28, 1996)
  • K962801 — SAFE MATE I.V. EXTENSION SETS (August 28, 1996)
  • K961327 — BEC NEEDLELESS INJECTION SITE (May 15, 1996)
  • K863635 — UPDATED STERILE ENDOTRACHEAL BRUSHES (November 3, 1986)
  • K863633 — SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES (October 16, 1986)
  • K863636 — UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS (October 6, 1986)
  • K863632 — UPDATED STERILE PROCEDURAL KIT (September 29, 1986)
  • K863637 — UPDATED STERILE GOWNS, MASKS AND TOWELS (September 29, 1986)
  • K851851 — STERILE ENDOTRACHEAL BRUSHES (June 5, 1985)

Other clearances for product code FMI

  • 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)
  • K253622 — Safety Pen Needle (March 18, 2026)
  • 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)

FDA data resources