Tray Dough
FDA 510(k) K911225 · The Hygenic Corp.
510(k) numberK911225
Submission
- Device name
- Tray Dough
- Applicant
- The Hygenic Corp.
Akron, OH, US - Received
- March 21, 1991
- Decision date
- April 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K930675 | Mitek Cone WasherKGS · Traditional | Mitek Surgical Products, Inc. | 11/09/1993SE |
| K904435 | Ventrofil Tension Relief Suture SetKGS · Traditional | Aesculap, Inc. | 08/29/1991SE |
| 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 |
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| K954990 | Dental DamEIE · Traditional | 01/26/1996SE |
| K930764 | Endo-Ice-Pulp Tester-ThermalEAT · Traditional | 05/27/1993SE |
| K905418 | Gates Glidden DrillsDZA · Traditional | 07/25/1991SE |
| K905640 | Solid Core Gutta Percha CarrierEKS · Traditional | 03/05/1991SE |
| K900301 | Novus Bonding AgentEBI · Traditional | 05/15/1990SE |
| K900844 | WedjetsEIE · Traditional | 04/16/1990SE |
| K894092 | Dental Endodontic Cement (Modification)KIF · Traditional | 01/10/1990SE |
| K881826 | Endo-IceEAT · Traditional | 08/23/1988SN |
| K873644 | Pulp PenEAT · Traditional | 10/27/1987SE |
| K863393 | EndocaterLQY · Traditional | 06/11/1987SE |
Questions and answers
When was Tray Dough cleared by the FDA?
Tray Dough (K911225) received a 510(k) decision of Substantially Equivalent on April 17, 1991, 27 days after the submission was received.
What is the product code of K911225?
The FDA product code is KGS – Retention Device, Suture, a Class I (low risk) device regulated under 21 CFR 878.4930.