Scanlan Sternum Needle-Suture
FDA 510(k) K801976 · Scanlan Intl., Inc.
510(k) numberK801976
Submission
- Device name
- Scanlan Sternum Needle-Suture
- Applicant
- Scanlan Intl., Inc.
Mchenry, IL, US - Received
- August 19, 1980
- Decision date
- September 26, 1980
- 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 |
| 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 |
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| K945474 | Scanlan(R) Thoracoscopic Scissors, Clamp, Forceps, Needle HolderGCJ · Traditional | 12/05/1994SE |
| K911184 | Scanlan/Taheri ValvulotomeMGZ · Traditional | 02/18/1992SE |
| K864920 | Scanlan (TM) Instrument TrayFSM · Traditional | 01/12/1987SE |
| K864919 | Scanlan (TM) Vein/Graft HolderKPK · Traditional | 01/12/1987SE |
| K851825 | Scanlan Tunneler, Sheath & TipDWS · Traditional | 07/12/1985SE |
| K841521 | Scanlan EndarsectorDWX · Traditional | 08/03/1984SE |
| K841513 | Scanlan Atraum Instrument Jaw Cover · Traditional | 07/06/1984SE |
| K841085 | Scanlan Colormark Skin MarkerFZZ · Traditional | 06/11/1984SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | 06/05/1984SE |
Questions and answers
When was Scanlan Sternum Needle-Suture cleared by the FDA?
Scanlan Sternum Needle-Suture (K801976) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 38 days after the submission was received.
What is the product code of K801976?
The FDA product code is GAB – Needle, Suturing, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.