Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting Tools
FDA 510(k) K953432 · Midas Rex Pneumatic Tools, Inc.
510(k) numberK953432
Submission
- Device name
- Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting Tools
- Applicant
- Midas Rex Pneumatic Tools, Inc.
Fort Worth, TX, US - Received
- July 21, 1995
- Decision date
- September 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GET – Motor, Surgical Instrument, Pneumatic Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960473 | Aesculap Power System HandpieceGET · Traditional | Aesculap, Inc. | 03/07/1996SE |
| K955174 | Sodem High Speed System for Neurosurgery & Median StyernotomyGET · Traditional | Sodem Diffusion SA | 01/22/1996SE |
| K942987 | Nucleotome L KitGET · Traditional | Surgical Dynamics, Inc. | 10/30/1995SE |
| K954076 | Midas Rex Drill Attachments & Twist DrillsGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 10/18/1995SE |
| K953433 | Midas Rex Telescoping SystemGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 09/15/1995SE |
| K952463 | GS & GS20 Surgical Tool SystemGET · Traditional | Midas Rex Pneumatic Tools, Inc. | 07/17/1995SE |
| K952300 | Midas Rex Motors (Midas I, II & Convertible Models)GET · Traditional | Midas Rex Pneumatic Tools, Inc. | 05/26/1995SE |
| K914753 | Auto Suture(R) Articulating Endoscopic ClampGET · Traditional | United States Surgical, A Division of Tyco Healthc | 06/11/1992SE |
| K910071 | Porta Gas Compressed Gas Cylinder CartGET · Traditional | Sen Tech Medical Corp. | 03/22/1991SE |
| K904578 | Modification Auto Suture(R) Endoscopic ClampGET · Traditional | United States Surgical, A Division of Tyco Healthc | 10/30/1990SE |
More from United States Surgical, A Division of Tyco Healthc
| 510(k) | Device | Decision |
|---|---|---|
| K972289 | Midas Rex MotorHBB · Traditional | 09/12/1997SE |
| K970965 | Midas Rex III Motor and Attachments (Midas III)ERL · Traditional | 04/09/1997SE |
| K962483 | Midas Rex III MotorHBB · Traditional | 11/19/1996SE |
| K953434 | Midas Rex Motors, (Midas I, Midas II & Convertible Models)HBB · Traditional | 05/16/1996SE |
| K954076 | Midas Rex Drill Attachments & Twist DrillsGET · Traditional | 10/18/1995SE |
| K953433 | Midas Rex Telescoping SystemGET · Traditional | 09/15/1995SE |
| K952463 | GS & GS20 Surgical Tool SystemGET · Traditional | 07/17/1995SE |
| K952300 | Midas Rex Motors (Midas I, II & Convertible Models)GET · Traditional | 05/26/1995SE |
| K900388 | Modified Sterilization of Drills, Burrs, TrephinesHBE · Traditional | 05/07/1990SE |
| K854462 | Midas Rex Surgical Rubber Dam · Traditional | 11/22/1985SE |
Questions and answers
When was Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting Tools cleared by the FDA?
Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting Tools (K953432) received a 510(k) decision of Substantially Equivalent on September 14, 1995, 55 days after the submission was received.
What is the product code of K953432?
The FDA product code is GET – Motor, Surgical Instrument, Pneumatic Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.