FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADT DISPOSABLE SCALPEL W/STAINLESS STEEL
K Number: K830745
·
Decision Apr 12, 1983
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
25
Applicant Total
2
Review Days
35
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
- ADT DISPOSABLE SCALPEL W/STAINLESS STEEL
- K Number
- K830745
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Lab Industries, Inc.
- Date Received
- March 8, 1983
- Decision Date
- April 12, 1983
- Product Code
- GDX
- 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 |
|---|---|---|---|
| GDX | Scalpel, One-Piece | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDX), ordered by most recent decision date.
SURGISTAR BLADES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ULTRABLADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ICAN CYLINDRICAL SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CCI CORNEAL SCARIFIER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
1-CUT ACL GRAFT KNIFE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VESSEL LOOPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Lab Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811771 | A.D.T. REUSABLE BONE MARROW NEEDLE | Jul 10, 1981 | Substantially Equivalent |