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510(k) K942863

EPIDURAL NEEDLE by Spinal Specialties, Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1995
Date Received
June 17, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Spinal Specialties, Inc.

  • K960100 — SPINAL SPECIALTIES NERVE BLOCK TRAY (April 24, 1996)
  • K960082 — DISCOGRAPHY KIT (March 21, 1996)
  • K944029 — CONTINUOUS EPIDURAL ANESTHESIA TRAY (June 30, 1995)
  • K943319 — GERTIE MARX EPI-SPINAL TRAY (June 30, 1995)
  • K950820 — SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE (June 30, 1995)
  • K941343 — SPINAL ANESTHESIA TRAY (August 11, 1994)
  • K935245 — EPIDURAL ANESTHESIA TRAY (May 2, 1994)

Other clearances for product code BSP

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  • K243525 — SonoTAP and SonoTAP II (March 24, 2025)
  • K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (November 22, 2024)
  • K241954 — SonoBlock; SonoBlock II (September 11, 2024)
  • K240253 — Reach Needle (March 21, 2024)
  • K212982 — Medispine - Spinal Needle, Glospine - Spinal Needle (July 29, 2022)
  • K211085 — BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (July 1, 2022)
  • K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (December 22, 2021)