Mitek Cone Washer
FDA 510(k) K930675 · Mitek Surgical Products, Inc.
510(k) numberK930675
Submission
- Device name
- Mitek Cone Washer
- Applicant
- Mitek Surgical Products, Inc.
Norwood, MA, US - Received
- February 9, 1993
- Decision date
- November 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGS – Retention Device, Suture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4930
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030031 | Soft Tissue Anchoring WashersKGS · Traditional | Accu-Speed, Incorporated | 01/28/2003SE |
| K020480 | RBMKGS · Special | Smith & Nephew, Inc. | 03/12/2002SE |
| K964935 | Suture LockKGS · Traditional | Smith & Nephew Endoscopy, Inc. | 02/25/1997SE |
| K941740 | Acufex Rotator Cuff Fixation ButtonKGS · Traditional | Acufex Microsurgical, Inc. | 06/30/1995SE |
| K904435 | Ventrofil Tension Relief Suture SetKGS · Traditional | Aesculap, Inc. | 08/29/1991SE |
| K911225 | Tray DoughKGS · Traditional | The Hygenic Corp. | 04/17/1991SE |
| K904136 | Suture Tension Adjustment ReelKGS · Traditional | Surgical Systems, Inc. | 10/02/1990SE |
| K902001 | Surgical Retention BarKGS · Traditional | Acufex Microsurgical, Inc. | 05/09/1990SE |
| K896310 | Acufex Fixation Button; Retention Bar, WedgeKGS · Traditional | Acufex Microsurgical, Inc. | 11/20/1989SE |
| K893995 | Dermacare Tie HolderKGS · Traditional | Dermacare | 08/11/1989SE |
More from Dermacare
| 510(k) | Device | Decision |
|---|---|---|
| K953560 | Mitek Threaded Anchor (Fastin)MBI · Traditional | 01/31/1996SN |
| K953877 | Mitek Gii AnchorMBI · Traditional | 12/29/1995SE |
| K936311 | Mitek Mini AnchorMNV · Traditional | 10/31/1995SN |
| K941599 | Mitek Absorbable AnchorMNV · Traditional | 10/24/1995SN |
| K944051 | Absorbalbe AnchorMNV · Traditional | 08/02/1995SE |
| K950070 | Mitek Toggle Anchor(Tm)JDR · Traditional | 05/22/1995SE |
| K944936 | Mitek G III Anchor, Mitek LS AnchorJDR · Traditional | 03/24/1995SE |
| K945203 | Mitek Thraded Anchor (Mta)JDR · Traditional | 03/06/1995SE |
| K934366 | Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue WasherHWC · Traditional | 10/07/1994SN |
| K931782 | Mitek Giii AnchorJDR · Traditional | 07/22/1994SN |
Questions and answers
When was Mitek Cone Washer cleared by the FDA?
Mitek Cone Washer (K930675) received a 510(k) decision of Substantially Equivalent on November 9, 1993, 273 days after the submission was received.
What is the product code of K930675?
The FDA product code is KGS – Retention Device, Suture, a Class I (low risk) device regulated under 21 CFR 878.4930.