Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port(Access Parts)
FDA 510(k) K960400 · Snowden-Pencer
510(k) numberK960400
Submission
- Device name
- Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port(Access Parts)
- Applicant
- Snowden-Pencer
Tucker, GA, US - Received
- January 29, 1996
- Decision date
- March 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBM – Cannula And Trocar, Suprapubic, Non-Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932021 | Entree Cannula Fascia AnchorsFBM · Traditional | Core Dynamics, Inc. | 01/11/1994SE |
| K911813 | Entree CannulaFBM · Traditional | Core Dynamics, Inc. | 07/19/1991SE |
| K900965 | GS-4550 Trocar Only, 11MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900964 | Cannula and Trocar, 11MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900963 | GS-4350 Trocar Only, 5.5MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900962 | GS-4300 Cannula and Trocar, 5.5MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900961 | GS-4100 Reducer Sleeve, 5MM to 3MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900955 | GS-4000 Reducer Sleeve, 11MM to 5MMFBM · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
More from Solos Endoscopy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030890 | SwitchbladeGEI · Traditional | 04/04/2003SE |
| K930666 | Reusable Laparoscopic Instruments W/ ElectrocauteryGEI · Traditional | 05/19/1994SE |
| K930667 | Reusable Laparoscopic InstrumentsGCJ · Traditional | 05/16/1994SE |
| K924148 | Diamond-Sharp(R) TrocarsHFI · Traditional | 02/28/1994SE |
| K924149 | Endo I/A ProbeGCJ · Traditional | 01/26/1993SE |
| K920985 | Snowden-Pencer Irrigation PumpHEI · Traditional | 06/09/1992SE |
| K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700HIF · Traditional | 06/04/1992SE |
| K913979 | Endo I/A Y SetHIF · Traditional | 11/27/1991SE |
| K913835 | Snowden-Pencer Insufflator Tubing SetHIF · Traditional | 11/07/1991SE |
| K861372 | Electrosurgical Cutting and Coagulation AccessoryGEI · Traditional | 06/19/1986SE |
Questions and answers
When was Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port(Access Parts) cleared by the FDA?
Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port(Access Parts) (K960400) received a 510(k) decision of Substantially Equivalent on March 12, 1996, 43 days after the submission was received.
What is the product code of K960400?
The FDA product code is FBM – Cannula And Trocar, Suprapubic, Non-Disposable, a Class I (low risk) device regulated under 21 CFR 876.5090.