FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS
K Number: K934172
·
Decision Oct 27, 1993
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
1
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
- ACRO-POLY, INC. HANDPIECE/ANGLEHEAD ACCESSORIES FOR SURGICAL INSTUMENTS
- K Number
- K934172
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Acro-Poly, Inc.
- Date Received
- August 27, 1993
- Decision Date
- October 27, 1993
- Product Code
- GEY
- 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEY), ordered by most recent decision date.
ADVANCED TURBO DRIVE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDNEXT 1000 DRILL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AQUA SPRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BONE AND MARROW COLLECTION SYSTEM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery