FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAX-I-GRASP
K Number: K854897
·
Decision May 2, 1986
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
16
Review Days
147
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
- MAX-I-GRASP
- K Number
- K854897
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Euro-Med Intl.
- Date Received
- December 6, 1985
- Decision Date
- May 2, 1986
- Product Code
- KDC
- 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 |
|---|---|---|---|
| KDC | Instrument, Surgical, Disposable | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KDC), ordered by most recent decision date.
DISPOSABLE SURGICAL SCISSORS AND FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THERMUFF BAG
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANUAL SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE CAUTERY ABRASIVE PAD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INSTRUMENT ORGANIZER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Euro-Med Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K883884 | PROSTATIC CORE-CUT NEEDLE | Dec 5, 1988 | Substantially Equivalent |
| K882404 | KEVOR-CURETTE | Jul 8, 1988 | Substantially Equivalent |
| K854894 | SPOON | May 2, 1986 | Substantially Equivalent |
| K854891 | KNIFE | May 2, 1986 | Substantially Equivalent |
| K854890 | HOOK PROBE | May 2, 1986 | Substantially Equivalent |
| K854898 | ATLANTIC GRASPER | May 2, 1986 | Substantially Equivalent |
| K854895 | BASKET FORCEP | May 2, 1986 | Substantially Equivalent |
| K854901 | PACIFIC GRASPER | May 2, 1986 | Substantially Equivalent |
| K854896 | HOOK SCISSOR | May 2, 1986 | Substantially Equivalent |
| K854889 | FLEX-I-GRASP | Feb 21, 1986 | Substantially Equivalent |