Standard Clamp
FDA 510(k) K153358 · Standard Bariatrics
510(k) numberK153358
Submission
- Device name
- Standard Clamp
- Applicant
- Standard Bariatrics
Cincinnati, OH, US - Received
- November 20, 2015
- Decision date
- May 2, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K895726 | Vessel OccluderGDJ · Traditional | Applied Medical Technologies | 10/24/1989SE |
| 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 |
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| K200517 | Standard TrocarGCJ · Traditional | 04/09/2020SE |
| K191885 | Standard BougieKNT · Traditional | 04/08/2020SE |
| K190788 | Disposable Standard ClampGCJ · Special | 04/18/2019SE |
| K181608 | Disposable Standard ClampGCJ · Traditional | 09/27/2018SE |
| K170379 | Disposable Standard ClampGCJ · Traditional | 07/19/2017SE |
Questions and answers
When was Standard Clamp cleared by the FDA?
Standard Clamp (K153358) received a 510(k) decision of Substantially Equivalent on May 2, 2016, 164 days after the submission was received.
What is the product code of K153358?
The FDA product code is GDJ – Clamp, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.