Cannulated Instrument Cleaners
FDA 510(k) K870765 · Treace Medical, Inc.
510(k) numberK870765
Submission
- Device name
- Cannulated Instrument Cleaners
- Applicant
- Treace Medical, Inc.
Memphis, TN, US - Received
- February 26, 1987
- Decision date
- May 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EKW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871493 | Denti-Tray(Tm)EKW · Traditional | Advanced Medical, Inc. | 06/24/1987SE |
| K862523 | Man Surg Instr/Access Dumbach Titan Mesh Impl SysEKW · Traditional | Walter Lorenz Surgical, Inc. | 08/01/1986SE |
| K831749 | Endodontic BROACH(76EKN) Barbed BroachEKW · Traditional | Union Branch | 07/12/1983SE |
| K823489 | Endodontic Broach-Barbed BroachEKW · Traditional | Union Broach, Div. Moyco Industries, Inc. | 12/15/1982SE |
| K800292 | Endex Broach, EndodonticEKW · Traditional | Ipco Corp. | 02/19/1980SE |
| K760985 | Hand InstrumentsEKW · Traditional | Adp Intl., Inc. | 11/15/1976SE |
More from Adp Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883727 | Bucket Prosthesis PorpETB · Traditional | 01/13/1989SE |
| K882349 | Mallet, SurgicalHXL · Traditional | 06/23/1988SE |
| K874779 | Bipolator 50GEI · Traditional | 01/29/1988SE |
| K873154 | Treace Magnum Oto-Tool SystemERL · Traditional | 09/04/1987SE |
| K872000 | Eye GardHOY · Traditional | 07/21/1987SE |
| K871706 | Optha PrepHMT · Traditional | 05/18/1987SE |
| K870759 | Cleaning Solution, Catalog No. 8203LRJ · Traditional | 05/07/1987SE |
| K870766 | Prosthesis WireETB · Traditional | 04/15/1987SE |
| K870764 | Schuknecht Wire Cutting Scissors · Traditional | 03/18/1987SE |
| K870763 | Super Scissors · Traditional | 03/18/1987SE |
Questions and answers
When was Cannulated Instrument Cleaners cleared by the FDA?
Cannulated Instrument Cleaners (K870765) received a 510(k) decision of Substantially Equivalent on May 27, 1987, 90 days after the submission was received.
What is the product code of K870765?
The FDA product code is EKW – Broach, Endodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.