FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUTZ NEEDLE
K Number: K013892
·
Decision Jul 11, 2002
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
26
Review Days
230
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Basic Information
- Device Name
- LUTZ NEEDLE
- K Number
- K013892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ballard Medical Products
- Date Received
- November 23, 2001
- Decision Date
- July 11, 2002
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K022398 | REUSABLE BRONCHIAL BIOPSY FORCEPS | Oct 11, 2002 | Substantially Equivalent |
| K000495 | BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES | Mar 28, 2000 | Substantially Equivalent |
| K993138 | BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT | Oct 20, 1999 | Substantially Equivalent |
| K990376 | BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME | May 3, 1999 | Substantially Equivalent |
| K982894 | MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT | Sep 11, 1998 | Substantially Equivalent |
| K974630 | 72 HOUR USE TRACH CARE WITH MICROBAN | Mar 11, 1998 | Substantially Equivalent |
| K964369 | TRACH CARE SET WITH MICROBAN | Feb 11, 1997 | Substantially Equivalent |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Jul 5, 1995 | Substantially Equivalent |
| K923487 | BAL CATH | Jul 30, 1993 | Unknown |