Contrast Background Material
FDA 510(k) K895681 · Applied Medical Technologies
510(k) numberK895681
Submission
- Device name
- Contrast Background Material
- Applicant
- Applied Medical Technologies
Independence, OH, US - Received
- September 21, 1989
- Decision date
- October 24, 1989
- 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 |
| 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 |
More from Scanlan Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971434 | A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceKNT · Traditional | 08/17/1998SE |
| K972478 | Pre-Loaded Replacement G-Tubes and AccessoriesKNT · Traditional | 02/09/1998SE |
| K973893 | Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring…KNT · Traditional | 12/19/1997SE |
| K971757 | Low Profile Feeding Set AccessoryKNT · Traditional | 11/07/1997SE |
| K971758 | Cauterization Smoke EvacuatorGEI · Traditional | 07/21/1997SE |
| K961345 | Domed Percutaneous Endoscopic Gastrostomy(P.E.G.) Feeding TubeKNT · Traditional | 09/17/1996SE |
| K960232 | Endoscopic Access DeviceGCJ · Traditional | 03/21/1996SE |
| K945618 | Gastrointestinal Tubes & AccessoriesKNT · Traditional | 10/12/1995SE |
| K946140 | PRG ButtonKNT · Traditional | 08/28/1995SE |
| K923488 | Gastranimal Percutaneous Replacement GastroomyKNT · Traditional | 07/20/1995SE |
Questions and answers
When was Contrast Background Material cleared by the FDA?
Contrast Background Material (K895681) received a 510(k) decision of Substantially Equivalent on October 24, 1989, 33 days after the submission was received.
What is the product code of K895681?
The FDA product code is GAB – Needle, Suturing, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.