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510(k) K882405

HYPODERMIC NEEDLE SHEATH HOLDER by Ansr Ent., Inc. — Product Code FMJ

K882405 is an FDA 510(k) premarket notification submitted by Ansr Ent., Inc. for the device "HYPODERMIC NEEDLE SHEATH HOLDER". The FDA issued a decision of Substantially Equivalent on June 29, 1988. The device falls under product code FMJ (Manometer, Spinal-Fluid), a Class II device regulated under 21 CFR 880.2500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1988
Date Received
June 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manometer, Spinal-Fluid
Device Class
Class II
Regulation Number
880.2500
Review Panel
HO
Submission Type

Other clearances for product code FMJ

  • K170305 — Spinal Manometer NRFit; Spinal Manometer LUER (July 25, 2017)
  • K032432 — BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER (August 28, 2003)
  • K970287 — LUMBAR PUNCTURE KIT (April 7, 1997)
  • K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (October 18, 1996)
  • K910089 — MEGA LUMBAR PUNCTURE KIT (June 20, 1991)

FDA data resources