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510(k) K962040

RNS ARTHROGRAM TRAY by Contour Fabricators of Florida, Inc. — Product Code FMI

K962040 is an FDA 510(k) premarket notification submitted by Contour Fabricators of Florida, Inc. for the device "RNS ARTHROGRAM TRAY". The FDA issued a decision of Substantially Equivalent on June 25, 1996. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Contour Fabricators of Florida, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1996
Date Received
May 24, 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 Contour Fabricators of Florida, Inc.

  • K955685 — RNS STERILE, DISPOSABLE CT BIOPSY TRAY (October 4, 1996)
  • K955687 — RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (June 3, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K955684 — RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY (May 2, 1996)
  • K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (March 12, 1996)
  • K955678 — RNS STERILE DISPOSABLE PUNCTURE TRAY (February 21, 1996)
  • K955688 — RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY (February 21, 1996)
  • K955686 — RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY (February 21, 1996)
  • K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (February 1, 1996)
  • K952395 — REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION (August 15, 1995)

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