Motor, Surgical Instrument, Pneumatic Powered
The Motor, Surgical Instrument, Pneumatic Powered (product code GET) is a pneumatically driven power source used to operate attachments such as drills, saws, and burrs during general and plastic surgery procedures. It is classified as an FDA Class 1 device, indicating the lowest risk level, subject to general controls only with no premarket notification required. Regulated under 21 CFR 878.4820 in the General, Plastic Surgery specialty (SU), this device has no special flags for implantation, life support, GMP exemption, or third-party review.
Basic Information
- Product Code
- GET
- Device Class
- FDA class 1
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960473 | AESCULAP POWER SYSTEM HANDPIECE | Mar 07, 1996 | Substantially Equivalent | AESCULAP, INC. |
| K955174 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY | Jan 22, 1996 | Substantially Equivalent | SODEM DIFFUSION SA |
| K942987 | NUCLEOTOME L KIT | Oct 30, 1995 | Substantially Equivalent | SURGICAL DYNAMICS, INC. |
| K954076 | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | Oct 18, 1995 | Substantially Equivalent | MIDAS REX PNEUMATIC TOOLS, INC. |
| K953433 | MIDAS REX TELESCOPING SYSTEM | Sep 15, 1995 | Substantially Equivalent | MIDAS REX PNEUMATIC TOOLS, INC. |
| K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS | Sep 14, 1995 | Substantially Equivalent | MIDAS REX PNEUMATIC TOOLS, INC. |
| K952463 | GS & GS20 SURGICAL TOOL SYSTEM | Jul 17, 1995 | Substantially Equivalent | MIDAS REX PNEUMATIC TOOLS, INC. |
| K952300 | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) | May 26, 1995 | Substantially Equivalent | MIDAS REX PNEUMATIC TOOLS, INC. |
| K914753 | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP | Jun 11, 1992 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K910071 | PORTA GAS COMPRESSED GAS CYLINDER CART | Mar 22, 1991 | Substantially Equivalent | SENTECH MEDICAL CORP. |
| K904578 | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP | Oct 30, 1990 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K885066 | HEMATOME SYSTEM | May 01, 1989 | Substantially Equivalent | SURGICAL DYNAMICS, INC. |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | Sep 16, 1987 | Substantially Equivalent | AMERICAN SILK SUTURES, INC. |
| K863447 | STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II | Sep 29, 1986 | Substantially Equivalent | STRYKER CORP. |
| K843498 | BIPOLAR SUCTION ELECTRODE | Dec 14, 1984 | Substantially Equivalent | EDER INSTRUMENT CO, INC. |
| K840370 | SURG-A-STAT VASECTOMY TIP | Jul 23, 1984 | Substantially Equivalent | SUNCOAST MEDICAL MANUFACTURERS, INC. |
| K833187 | HALL OSTEON | Oct 31, 1983 | Substantially Equivalent | AMSCO CO. |
| K832188 | HALL RECIPROCATOR | Aug 12, 1983 | Substantially Equivalent | AMSCO CO. |
| K832187 | HALL OSCILLATOR | Aug 12, 1983 | Substantially Equivalent | AMSCO CO. |
| K832186 | HALL DRILL/REAMER | Aug 12, 1983 | Substantially Equivalent | AMSCO CO. |
| K831675 | TWIST LOCK DRILL 1120 | Jun 30, 1983 | Substantially Equivalent | MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
| K800382 | CLEAR-VIEW MIRROR WARMER | May 14, 1980 | Substantially Equivalent | SURGICAL MECHANICAL RESEARCH, INC. |
| K790195 | FOOT VALVE | Feb 26, 1979 | Substantially Equivalent | AMERICAN SAFETY |
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.