Needle Driver
FDA 510(k) K780255 · Scanlan Intl., Inc.
510(k) numberK780255
Submission
- Device name
- Needle Driver
- Applicant
- Scanlan Intl., Inc.
Mchenry, IL, US - Received
- February 16, 1978
- Decision date
- April 18, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFC – Driver, Surgical, Pin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GFC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K781450 | DriversGFC · Traditional | Orthopedic Equipment Co., Inc. | 09/27/1978SE |
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| 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 Needle Driver cleared by the FDA?
Needle Driver (K780255) received a 510(k) decision of Substantially Equivalent on April 18, 1978, 61 days after the submission was received.
What is the product code of K780255?
The FDA product code is GFC – Driver, Surgical, Pin, a Class I (low risk) device regulated under 21 CFR 878.4820.