FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPICAN EPIDURAL CANNULA, BEVEL ACCORD
K Number: K813236
·
Decision Dec 3, 1981
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
41
Review Days
23
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
- EPICAN EPIDURAL CANNULA, BEVEL ACCORD
- K Number
- K813236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Burron Medical Products, Inc.
- Date Received
- November 10, 1981
- Decision Date
- December 3, 1981
- 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 Burron Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870403 | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE | May 1, 1987 | Substantially Equivalent |
| K862412 | INTESTOPLANT | Nov 13, 1986 | Substantially Equivalent |
| K861479 | CAVAFIX, CENTRAL VENOUS CATHETER KIT | Jul 1, 1986 | Unknown |
| K860126 | STIMUPLEX, NERVE STIMULATOR | Feb 28, 1986 | Substantially Equivalent |
| K851293 | IMPLANTOFIX | Jan 9, 1986 | Substantially Equivalent |
| K841428 | JEJUNOSTOMY SET FOR TUBE FEEDING | Jul 9, 1984 | Substantially Equivalent |
| K834383 | DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT | May 1, 1984 | Substantially Equivalent |
| K834299 | LONG TERM CENTRAL VENOUS ACCESS CATH | May 1, 1984 | Substantially Equivalent |
| K834473 | MULTI-LUMEN CENTRAL VENOUS CATH. KIT | Apr 30, 1984 | Substantially Equivalent |
| K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | Feb 24, 1984 | Substantially Equivalent |