FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EASY-ON
K Number: K932998
·
Decision Aug 18, 1993
Classifications
1
FEI Numbers
300
Registration Numbers
300
Same Product Code
47
Applicant Total
47
Review Days
61
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
- EASY-ON
- K Number
- K932998
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Devon Industries, Inc.
- Date Received
- June 18, 1993
- Decision Date
- August 18, 1993
- Product Code
- GES
- 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 |
|---|---|---|---|
| GES | Blade, Scalpel | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GES), ordered by most recent decision date.
PERSONNA PLUS SAFETY SCALPEL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LOS ALAMOS RETRACTABLE KNIFE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SCALPEL BLADE REMOVER (BLADEGARD)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PRECISION GLIDE - ENHANCED SURGICAL BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERILE CARBON STEEL SURGICAL BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Devon Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961993 | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | Jul 3, 1996 | Substantially Equivalent |
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | Nov 20, 1995 | Substantially Equivalent |
| K946289 | DEVONS POINT LOK NEEDLE PROTECTION DEVICE | Jul 10, 1995 | Substantially Equivalent |
| K945197 | THE SHARPS COLLECTION AND DISPOSAL SYSTEM | Dec 2, 1994 | Substantially Equivalent |
| K943892 | POINT OF USE SHARPS A GATOR | Dec 2, 1994 | Substantially Equivalent |
| K944114 | PHLEBOTOMY UNIT SHARPS A GATOR | Dec 2, 1994 | Substantially Equivalent |
| K945485 | ABG NEEDLE PROTECTION | Nov 29, 1994 | Substantially Equivalent |
| K912824 | DEVON SPONGE COUNTER BAGS | Aug 26, 1991 | Substantially Equivalent |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Sep 7, 1989 | Substantially Equivalent |
| K892660 | HIBERNATION KIT | Aug 15, 1989 | Substantially Equivalent |