Wyman Suture Washer
FDA 510(k) K910186 · Acu Med, Inc.
510(k) numberK910186
Submission
- Device name
- Wyman Suture Washer
- Applicant
- Acu Med, Inc.
Beaverton, OR, US - Received
- January 15, 1991
- Decision date
- July 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
|---|---|---|
| K021321 | Wrist Fusion PlateHRS · Traditional | 07/17/2002SE |
| K013616 | Polarus Cap ScrewHSB · Traditional | 12/19/2001SE |
| K012655 | Congruent Bone Plate SystemHRS · Traditional | 11/07/2001SE |
| K992525 | Acumed Modular Shoulder SystemHSD · Traditional | 02/04/2000SE |
| K993657 | Acumed Suture AnchorMBI · Traditional | 01/13/2000SE |
| K980103 | Acumed Suture AnchorMBI · Traditional | 03/16/1998SE |
| K965028 | Acumed Suture WasherHTN · Traditional | 03/17/1997SE |
| K965029 | Stableloc II External FixatorJEC · Traditional | 02/19/1997SE |
| K964500 | Acumed Tension Band PinHTY · Traditional | 12/09/1996SE |
| K963026 | TBDHSB · Traditional | 10/28/1996SE |
Questions and answers
When was Wyman Suture Washer cleared by the FDA?
Wyman Suture Washer (K910186) received a 510(k) decision of Substantially Equivalent on July 25, 1991, 191 days after the submission was received.
What is the product code of K910186?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.