FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO Z DISPOS. SPINAL ANESTH. NEEDLE
K Number: K832126
·
Decision Aug 12, 1983
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
9
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MICRO Z DISPOS. SPINAL ANESTH. NEEDLE
- K Number
- K832126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Smith & Nephew, Mpl Division
- Date Received
- July 1, 1983
- Decision Date
- August 12, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSP), ordered by most recent decision date.
SonoMSK
FDA 510(k)
FDA Class 2
·Anesthesiology
SonoPlex STIM; SonoPlex II
FDA 510(k)
FDA Class 2
·Anesthesiology
SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
FDA 510(k)
FDA Class 2
·Anesthesiology
SonoTAP and SonoTAP II
FDA 510(k)
FDA Class 2
·Anesthesiology
SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
FDA 510(k)
FDA Class 2
·Anesthesiology
SonoBlock; SonoBlock II
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Smith & Nephew, Mpl Division
| K Number | Device Name | ||
|---|---|---|---|
| K843314 | MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE | Sep 27, 1984 | Substantially Equivalent |
| K841280 | SOLOPAK BRAND FILTER NEEDLE W/5 MICRO | May 21, 1984 | Substantially Equivalent |
| K840237 | MAX-I-PROBE PERIODONTAL ENDODONTIC PROB | Apr 5, 1984 | Substantially Equivalent |
| K833304 | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | Mar 30, 1984 | Substantially Equivalent |
| K831765 | HERAPIN LOCK FLUSH SOLUTION USE KIT | Jul 12, 1983 | Substantially Equivalent |
| K830524 | HENKE JECT PRESSURE SYRINGE | Mar 24, 1983 | Substantially Equivalent |
| K830242 | MICRO 2 HYPODERMIC NEEDLES | Feb 15, 1983 | Substantially Equivalent |
| K761206 | INTEROSSEOUS NEEDLE | Dec 13, 1976 | Substantially Equivalent |