FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AESCULAP POWER SYSTEM HANDPIECE
K Number: K960473
·
Decision Mar 7, 1996
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
174
Review Days
35
Basic Information
- Device Name
- AESCULAP POWER SYSTEM HANDPIECE
- K Number
- K960473
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AESCULAP, INC.
- Date Received
- February 1, 1996
- Decision Date
- March 7, 1996
- Product Code
- GET
- 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 |
|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by AESCULAP, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K152960 | ELAN 4 Motor System | Jul 22, 2016 | Substantially Equivalent |
| K160393 | AdTec | May 26, 2016 | Substantially Equivalent |
| K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Feb 17, 2016 | Substantially Equivalent |
| K151865 | PremiPatch PTFE Pledget | Oct 27, 2015 | Substantially Equivalent |
| K143729 | SterilContainer S | Aug 18, 2015 | Substantially Equivalent |
| K151696 | Caiman Seal and Cut Technology | Jul 20, 2015 | Substantially Equivalent |
| K142970 | SterilContainer S System | Jul 8, 2015 | Substantially Equivalent |
| K141687 | AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM | Apr 2, 2015 | Substantially Equivalent |
| K142315 | MINOP Disposable Introducer 26F | Nov 14, 2014 | Substantially Equivalent |
| K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Jul 15, 2014 | Substantially Equivalent |