Silicone Instrument Shods
FDA 510(k) K895591 · Key Surgical, Inc.
510(k) numberK895591
Submission
- Device name
- Silicone Instrument Shods
- Applicant
- Key Surgical, Inc.
Minneapolis, MN, US - Received
- September 15, 1989
- Decision date
- October 20, 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K895726 | Vessel OccluderGDJ · Traditional | Applied Medical Technologies | 10/24/1989SE |
| 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 |
|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle CoverFTA · Traditional | 09/22/2015SE |
| K151222 | Cautery Tip CleanerGEI · Traditional | 05/22/2015SE |
| K910328 | Key Comfort GripsFSM · Traditional | 03/06/1991SE |
| K896676 | Key Vascular LoopsKDC · Traditional | 02/27/1990SE |
| K896472 | Key Vascular BootiesMAW · Traditional | 12/14/1989SE |
Questions and answers
When was Silicone Instrument Shods cleared by the FDA?
Silicone Instrument Shods (K895591) received a 510(k) decision of Substantially Equivalent on October 20, 1989, 35 days after the submission was received.
What is the product code of K895591?
The FDA product code is GDJ – Clamp, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.