Vessel Occluder
FDA 510(k) K895726 · Applied Medical Technologies
510(k) numberK895726
Submission
- Device name
- Vessel Occluder
- Applicant
- Applied Medical Technologies
Independence, OH, US - Received
- September 25, 1989
- Decision date
- October 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDJ – Clamp, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDJ
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|---|---|---|---|
| K153358 | Standard ClampGDJ · Traditional | Standard Bariatrics | 05/02/2016SE |
| K930315 | Thoracic Clamps: Sarot, Kantowitz and LawrenceGDJ · Traditional | Thomasville Medical Assoc. | 02/04/1994SE |
| K924223 | Mar-Med Liver StrapGDJ · Traditional | Mar-Med Co. | 03/18/1993SE |
| K922659 | General Surgery Clamp and Needle HolderGDJ · Traditional | Miltex Instrument Co. | 07/21/1992SE |
| K914913 | Grice Foot Pedal Control/Reddick Irri/Aspir SystGDJ · Traditional | Ideal Medical, Inc. | 12/31/1991SE |
| K900956 | GS-7100 Cholangiogram Clamp, 5MMGDJ · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K901107 | Modified Auto Suture Purstring Disp. AutomaticGDJ · Traditional | United States Surgical, A Division of Tyco Healthc | 04/09/1990SE |
| K895591 | Silicone Instrument ShodsGDJ · Traditional | Key Surgical, Inc. | 10/20/1989SE |
| K882169 | Surgical Duct Clamp (Vine)GDJ · Traditional | Henley Intl. | 06/17/1988SE |
| K881741 | Stuart Lee ClipGDJ · Traditional | Stuart-Lee, Inc. | 06/03/1988SE |
More from Stuart-Lee, 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 Vessel Occluder cleared by the FDA?
Vessel Occluder (K895726) received a 510(k) decision of Substantially Equivalent on October 24, 1989, 29 days after the submission was received.
What is the product code of K895726?
The FDA product code is GDJ – Clamp, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.