Labeling for Myo/Wire II Sternotomy Sutures
FDA 510(k) K932513 · Alto Development Corp.
510(k) numberK932513
Submission
- Device name
- Labeling for Myo/Wire II Sternotomy Sutures
- Applicant
- Alto Development Corp.
Farmingdale, NJ, US - Received
- May 25, 1993
- Decision date
- January 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GAO – Suture, Nonabsorbable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4495
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GAO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872532 | Auto Suture Stainless Steel Sutures*GAO · Traditional | United States Surgical, A Division of Tyco Healthc | 08/05/1987SE |
| K863034 | Sharpoint Stainless Steel SutureGAO · Traditional | Chathamborough Research Group, Inc. | 09/30/1986SE |
| K802248 | Disarp OriginalGAO · Traditional | Unoplast A/S | 09/26/1980SE |
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| K931537 | A&E Medical Electrosurg Electro W/Non-Stick CoatGEI · Traditional | 09/07/1993SE |
| K930528 | A&E Medical Electrosurgical Connecting CordsGEI · Traditional | 05/17/1993SE |
| K914193 | A&E Medical Corp Dispos Suct Coag W/Non Stick CoatGEI · Traditional | 10/05/1992SE |
| K915300 | A & Em Medical Electrosurgical Pencil/AccessoriesGEI · Traditional | 02/18/1992SE |
| K884783 | Raney ClipFZQ · Traditional | 11/30/1988SE |
| K881413 | Electro-Cautery Suction TubeGEI · Traditional | 04/21/1988SE |
| K831867 | Pressure Monitoring IV Bottle CapDRS · Traditional | 08/12/1983SE |
| K821518 | Myo/ClipLDF · Traditional | 07/08/1982SE |
Questions and answers
When was Labeling for Myo/Wire II Sternotomy Sutures cleared by the FDA?
Labeling for Myo/Wire II Sternotomy Sutures (K932513) received a 510(k) decision of Substantially Equivalent on January 7, 1994, 227 days after the submission was received.
What is the product code of K932513?
The FDA product code is GAO – Suture, Nonabsorbable, a Class II (moderate risk) device regulated under 21 CFR 878.4495.