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510(k) K013892

LUTZ NEEDLE by Ballard Medical Products — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2002
Date Received
November 23, 2001
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 Ballard Medical Products

  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K022398 — REUSABLE BRONCHIAL BIOPSY FORCEPS (October 11, 2002)
  • K000495 — BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (March 28, 2000)
  • K993138 — BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT (October 20, 1999)
  • K990376 — BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME (May 3, 1999)
  • K982894 — MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT (September 11, 1998)
  • K974630 — 72 HOUR USE TRACH CARE WITH MICROBAN (March 11, 1998)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)
  • K923487 — BAL CATH (July 30, 1993)

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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)
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