HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment Class I
FDA product code HWE covers "Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment", a Class I medical device regulated under 21 CFR 878.4820. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HWE
- Device Class
- Class I
- Regulation Number
- 878.4820
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K143191 | mcginley innovations | IntelliSense Drill | February 20, 2015 |
| K102743 | ortho solutions limited | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | January 20, 2011 |
| K063688 | anspach effort | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | January 16, 2007 |
| K050766 | zimmer trabecular | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | May 26, 2005 |
| K043310 | synthes (usa) | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | January 5, 2005 |
| K022744 | medical device services | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | September 18, 2002 |
| K012694 | adven medical | REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS | February 4, 2002 |
| K012676 | adven medical | REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS | February 4, 2002 |
| K990816 | modular cutting systems | AVCORE SYSTEM | September 24, 1999 |
| K973736 | aesculap | AESCULAP HILAN MOTOR SYSTEM | December 29, 1997 |
| K973560 | ds mfg | BONE GRAFT HARVESTER | November 12, 1997 |
| K972508 | synvasive technology | SURGICAL BURS AND SURGICAL DRILL BITS | August 26, 1997 |
| K971342 | disk whisk | DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) | July 8, 1997 |
| K971544 | synthes (usa) | SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) | May 28, 1997 |
| K962087 | medicon | SERVOTRONIC EC100 SYSTEM | April 23, 1997 |
| K970088 | richard wolf medical instruments | RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES | April 7, 1997 |
| K970023 | mednext | MEDNEXT SURGICAL BUR | February 28, 1997 |
| K970040 | spine-tech | SPINE-TECH BONE HARVESTER | February 28, 1997 |
| K962913 | synthes (usa) | SYNTHES STERILE DRILL BITS | November 14, 1996 |
| K962800 | stryker instruments | STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES | September 11, 1996 |