510(k) K952300
- Device
- MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS)
- Applicant
- MIDAS REX PNEUMATIC TOOLS, INC.
- 510(k) number
- K952300
- Product code
- GET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-26
- Date received
- 1995-05-16
- Regulation
- 878.4820
- Classification name
- Motor, Surgical Instrument, Pneumatic Powered
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD A HAMER
- Address
- P.O. Box 16598 Fort Worth TX US 76102 76102
FDA Registration Numbers#
- 3003079267
- 1058584
- 3004962786
- 3015276580
- 3025936823
- 1625507
- 2647580
- 3032391
- 3008110533
- 1423662
- 1836161
- 1320894
- 3022320321
- 2916714
- 3007305485
- 3030956508
- 3010656982
- 1018470
- 3011495120
- 3004940685
- 3005180920
- 3003587896
- 3018094310
- 3015453963
- 1219930
- 8043750
- 1000606483
- 1017294
- 3008787426
- 3009599228
- 8030607
- 3010141593
- 3014461810
- 1030489
- 1828464
- 2020601
- 3039169546
- 3004264602
- 3005061536
- 9610612
- 3003120897
- 3013893019
- 1828288
- 3017210488
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GET #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960473 | AESCULAP POWER SYSTEM HANDPIECE | Aesculap, Inc. | 1996-03-07 |
| K955174 | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY | Sodem Diffusion SA | 1996-01-22 |
| K942987 | NUCLEOTOME L KIT | Surgical Dynamics, Inc. | 1995-10-30 |
| K954076 | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | Midas Rex Pneumatic Tools, Inc. | 1995-10-18 |
| K953433 | MIDAS REX TELESCOPING SYSTEM | Midas Rex Pneumatic Tools, Inc. | 1995-09-15 |
| K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS | Midas Rex Pneumatic Tools, Inc. | 1995-09-14 |
| K952463 | GS & GS20 SURGICAL TOOL SYSTEM | Midas Rex Pneumatic Tools, Inc. | 1995-07-17 |
| K914753 | AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | 1992-06-11 |
| K910071 | PORTA GAS COMPRESSED GAS CYLINDER CART | Sen Tech Medical Corp. | 1991-03-22 |
| K904578 | MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | 1990-10-30 |
| K885066 | HEMATOME SYSTEM | Surgical Dynamics, Inc. | 1989-05-01 |
| K872951 | AMERICAN BRAIN RETRACTOR COVER | American Silk Sutures, Inc. | 1987-09-16 |
| K863447 | STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II | Stryker Corp. | 1986-09-29 |
| K843498 | BIPOLAR SUCTION ELECTRODE | Eder Instrument Co, Inc. | 1984-12-14 |
| K840370 | SURG-A-STAT VASECTOMY TIP | Suncoast Medical Manufacturers, Inc. | 1984-07-23 |
Legacy Summary#
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FDA Review#
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