FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATRAUMATIC SPECIAL SPROTTE NEEDLE
K Number: K911221
·
Decision Jul 24, 1992
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
19
Review Days
493
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Basic Information
- Device Name
- ATRAUMATIC SPECIAL SPROTTE NEEDLE
- K Number
- K911221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pajunk GmbH
- Date Received
- March 19, 1991
- Decision Date
- July 24, 1992
- 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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| K060563 | EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV | Jun 2, 2006 | Substantially Equivalent |
| K053283 | UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET | Jan 12, 2006 | Substantially Equivalent |
| K053282 | ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP | Dec 13, 2005 | Substantially Equivalent |
| K043130 | MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS | Dec 21, 2004 | Substantially Equivalent |
| K042979 | MODIFICATION TO: PLEXALONG SETS | Dec 21, 2004 | Substantially Equivalent |
| K040965 | PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES | Sep 7, 2004 | Substantially Equivalent |
| K033018 | STIMULONG PLUS CATHETER SET MODEL, VARIOUS | May 5, 2004 | Substantially Equivalent |
| K033249 | PAJUNK MODULAR HANDLE INSTRUMENTS | Mar 5, 2004 | Substantially Equivalent |