Thoracic Clamps: Sarot, Kantowitz and Lawrence
FDA 510(k) K930315 · Thomasville Medical Assoc.
510(k) numberK930315
Submission
- Device name
- Thoracic Clamps: Sarot, Kantowitz and Lawrence
- Applicant
- Thomasville Medical Assoc.
Alpharetta, GA, US - Received
- January 22, 1993
- Decision date
- February 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K153358 | Standard ClampGDJ · Traditional | Standard Bariatrics | 05/02/2016SE |
| 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 |
More from Stuart-Lee, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K926429 | Vaginal Specula: Cusco, Guttman, InfantHDF · Traditional | 02/28/1994SE |
| K930030 | Suction Tubes: House, BaronJCX · Traditional | 02/25/1994SE |
| K926540 | Sopher and Bierer Ovum ForcepsHLZ · Traditional | 02/25/1994SE |
| K926536 | Disposable Plastic Vaginal SpeculaHIB · Traditional | 02/25/1994SE |
| K926535 | Gomco Circumcision ClampHFX · Traditional | 02/25/1994SE |
| K926533 | Z-Clamp ForcepsHCZ · Traditional | 02/25/1994SE |
| K926532 | Endo Cervical CuretteKNA · Traditional | 02/25/1994SE |
| K926531 | Hysterectomy ForcepsHCZ · Traditional | 02/25/1994SE |
| K926527 | Roto Fit Biopsy ForcepsHFB · Traditional | 02/25/1994SE |
| K926484 | Corson Myoma Grasping ForcepsHCZ · Traditional | 02/25/1994SE |
Questions and answers
When was Thoracic Clamps: Sarot, Kantowitz and Lawrence cleared by the FDA?
Thoracic Clamps: Sarot, Kantowitz and Lawrence (K930315) received a 510(k) decision of Substantially Equivalent on February 4, 1994, 378 days after the submission was received.
What is the product code of K930315?
The FDA product code is GDJ – Clamp, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.