FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADAIR/VERESS NEEDLE INTRODUCER SET
K Number: K930568
·
Decision Jul 22, 1993
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
7
Applicant Total
18
Review Days
177
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
- ADAIR/VERESS NEEDLE INTRODUCER SET
- K Number
- K930568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Dynamics, Inc.
- Date Received
- January 26, 1993
- Decision Date
- July 22, 1993
- Product Code
- GCB
- 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 |
|---|---|---|---|
| GCB | Needle, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCB), ordered by most recent decision date.
Valved Safety Centesis Catheter
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PARACENTESIS CATHETER DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TURKEL PNEUMOTHORAX KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ADAIR/VERESS NEEDLE INTRODUCER SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANAN EPIDURAL NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Medical Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974542 | TRUE VISION, TRUE VISION II | Feb 17, 1998 | Substantially Equivalent |
| K921294 | VIDEO ENDOSCOPE-RIGID MODIFICATION | Jul 20, 1994 | Substantially Equivalent |
| K934682 | SURGICAL VIDEO CAMERA AND ACCESSORIES | Feb 15, 1994 | Substantially Equivalent |
| K915538 | OVER THE WIRE STONE BASKET | Mar 20, 1992 | Substantially Equivalent |
| K914315 | OPTICAL CATHETER INTRODUCER SETS, MODIFICATION | Mar 4, 1992 | Substantially Equivalent |
| K913986 | CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM | Jan 28, 1992 | Unknown |
| K911296 | OPTICAL CATHETER ARTHROSCOPE | Sep 24, 1991 | Substantially Equivalent |
| K903339 | VIDEO ENDOSCOPE, RIGID | Mar 6, 1991 | Substantially Equivalent |
| K904609 | XENON LIGHT SOURCE | Dec 18, 1990 | Substantially Equivalent |
| K904113 | OPERATIVE RECORDING CAMERA | Oct 30, 1990 | Substantially Equivalent |