Digicap
FDA 510(k) K012199 · Humana USA, Inc.
510(k) numberK012199
Submission
- Device name
- Digicap
- Applicant
- Humana USA, Inc.
Bethesda, MD, US - Received
- July 13, 2001
- Decision date
- December 19, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K863595 | Coated Suture NeedleGAB · Traditional | Sharpoint, Inc. | 10/24/1986SE |
| 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 |
Questions and answers
When was Digicap cleared by the FDA?
Digicap (K012199) received a 510(k) decision of Substantially Equivalent on December 19, 2001, 159 days after the submission was received.
What is the product code of K012199?
The FDA product code is GAB – Needle, Suturing, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.