FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
K Number: K974295
·
Decision Feb 10, 1998
Classifications
1
FEI Numbers
214
Registration Numbers
214
Same Product Code
28
Applicant Total
27
Review Days
88
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
- BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
- K Number
- K974295
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Byron Medical
- Date Received
- November 14, 1997
- Decision Date
- February 10, 1998
- Product Code
- KGZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGZ | Accessories, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGZ), ordered by most recent decision date.
AART SILICONE TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WOUND DRAINAGE HOLDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DURALASTIC SILICONE TUBING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAVARRE PERCUTANEOUS ACCESS SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PALESTRANT IRRIGATION AND DRAINAGE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OPTICAL CATHETER(TM) INTRODUCER SETS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Byron Medical
| K Number | Device Name | ||
|---|---|---|---|
| K040149 | PSI-TEC PERISTALTIC INFILTRATION PUMP | Jun 3, 2004 | Substantially Equivalent |
| K001803 | ACCELERATOR RECIPROCATING CANNULA | Aug 4, 2000 | Substantially Equivalent |
| K981215 | PSI-TEC LIPOSUCTION ASPIRATOR | Jul 1, 1998 | Substantially Equivalent |
| K981172 | LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES | Jun 30, 1998 | Substantially Equivalent |
| K980738 | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION | Jun 16, 1998 | Substantially Equivalent |
| K980392 | PSI-TEC ASPIRATOR | Mar 5, 1998 | Substantially Equivalent |
| K973133 | BIG BAG 3000 PRESSURE INFUSOR | Sep 12, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K934179 | DISPOSABLE BAG DECANTER | May 23, 1994 | Substantially Equivalent |
| K934233 | ZARA ZONE IV MALAR IMPLANT MODIFICATION | Feb 3, 1994 | Substantially Equivalent |
| K933670 | BIOPSY PUNCH, SURGICAL | Jan 7, 1994 | Substantially Equivalent |