FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K Number: K932400
·
Decision Dec 13, 1993
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
19
Review Days
209
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
- ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
- K Number
- K932400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- B. Braun of America, Inc.
- Date Received
- May 18, 1993
- Decision Date
- December 13, 1993
- 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 B. Braun of America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER | Mar 13, 2000 | Substantially Equivalent |
| K983794 | CHEMO MINI SPIKE PLUS | Mar 23, 1999 | Substantially Equivalent |
| K946170 | COMFORT-Q SUBCUTANEOUS INJECTION SETS | Nov 3, 1995 | Substantially Equivalent |
| K945850 | BRAUN DIACAN(R) FISTULA NEEDLES | Oct 6, 1995 | Substantially Equivalent |
| K942988 | FILTERED EXTENSION SETS | Jul 14, 1995 | Substantially Equivalent |
| K945752 | CELSITE(TM) BRACHIAL VENOUS PORT | May 31, 1995 | Substantially Equivalent |
| K945551 | CELSITE(TM) DUAL VENOUS SYSTEM | Apr 21, 1995 | Substantially Equivalent |
| K943770 | LOW VOLUME MULTIPORT | Apr 10, 1995 | Substantially Equivalent |
| K950982 | B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE | Apr 4, 1995 | Substantially Equivalent |
| K950184 | B. BRAUN IV START KITS | Mar 15, 1995 | Unknown |