Coated Suture Needle
FDA 510(k) K863595 · Sharpoint, Inc.
510(k) numberK863595
Submission
- Device name
- Coated Suture Needle
- Applicant
- Sharpoint, Inc.
Reading, PA, US - Received
- September 15, 1986
- Decision date
- October 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAB – Needle, Suturing, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GAB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012199 | DigicapGAB · Traditional | Humana USA, Inc. | 12/19/2001SE |
| K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)GAB · Traditional | Axya Medical, Inc. | 05/11/1998SE |
| K932591 | Endo-JudgeGAB · Traditional | Synergistic Medical Technologies, Inc. | 12/22/1993SE |
| K895681 | Contrast Background MaterialGAB · Traditional | Applied Medical Technologies | 10/24/1989SE |
| K831648 | Anchor Brand Surgical NeedlesGAB · Traditional | Anchor Products Co. | 08/16/1983SE |
| K812444 | Radiation Sterilization for Needle CNTRGAB · Traditional | Devon Industries, Inc. | 12/14/1981SE |
| K801976 | Scanlan Sternum Needle-SutureGAB · Traditional | Scanlan Intl., Inc. | 09/26/1980SE |
More from Scanlan Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861947 | Surgical KnifeEMF · Traditional | 06/06/1986SE |
| K840764 | Ear KnivesJYO · Traditional | 05/21/1984SE |
| K840855 | Corneal Scleral LanceHNN · Traditional | 05/09/1984SE |
| K840660 | Posterior Capsulotomy CystitomeHNY · Traditional | 03/16/1984SE |
| K840659 | Anterior Capsulectomy CystitomeHNY · Traditional | 03/16/1984SE |
| K830522 | Stainless Steel Suture 316L · Traditional | 03/31/1983SE |
| K822112 | Ophthalmic KnifeHNN · Traditional | 08/10/1982SE |
| K821440 | V LanceHNN · Traditional | 06/14/1982SE |
Questions and answers
When was Coated Suture Needle cleared by the FDA?
Coated Suture Needle (K863595) received a 510(k) decision of Substantially Equivalent on October 24, 1986, 39 days after the submission was received.
What is the product code of K863595?
The FDA product code is GAB – Needle, Suturing, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.