Sigmoidoscope/ Disposable
FDA 510(k) K761180 · Smithkline Diagnostics, Inc.
510(k) numberK761180
Submission
- Device name
- Sigmoidoscope/ Disposable
- Applicant
- Smithkline Diagnostics, Inc.
Mchenry, IL, US - Received
- December 2, 1976
- Decision date
- January 5, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAM – Sigmoidoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
to examine and perform procedures within the sigmoid (descending) colon
Other 510(k)s with product code FAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964131 | EndoscopeFAM · Traditional | Akos Biomedical, Inc. | 06/27/1997SE |
| K970382 | VS-100 Video SigmoidoscopeFAM · Traditional | Welch Allyn, Inc. | 04/17/1997SE |
| K964326 | Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with Endosheath SystemFAM · Traditional | Vision-Sciences, Inc. | 01/03/1997SE |
| K964100 | Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic…FAM · Traditional | Vision-Sciences, Inc. | 12/16/1996SE |
| K963344 | Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic SigmoidoscopeFAM · Traditional | Vision-Sciences, Inc. | 11/21/1996SE |
| K961567 | ES-3840, Video SigmoidoscopeFAM · Traditional | Pentax Precision Instrument Corp. | 06/24/1996SE |
| K951577 | ES-3800, Video SigmoidoscopeFAM · Traditional | Pentax Precision Instrument Corp. | 03/21/1996SE |
| K950429 | Video SigmoidoscopeFAM · Traditional | Welch Allyn, Inc. | 08/01/1995SE |
| K951576 | FS-34P2, Fiber SigmoidoscopeFAM · Traditional | Pentax Precision Instrument Corp. | 06/29/1995SE |
| K951573 | FS-38H, Fiber SigmoidoscopeFAM · Traditional | Pentax Precision Instrument Corp. | 06/27/1995SE |
More from Pentax Precision Instrument Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K961062 | Flexsure ObtKHE · Traditional | 11/06/1996SE |
| K960183 | Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for…LYR · Traditional | 06/07/1996SE |
| K934863 | Flexsure HPLYR · Traditional | 05/18/1994SE |
| K880499 | Hemoccult Sensitive TestKHE · Traditional | 05/23/1988SE |
| K875131 | (SKD) Cholesterol Test KitCHH · Traditional | 03/01/1988SE |
| K862849 | Hemoccult Wipe TestKHE · Traditional | 12/09/1986SE |
| K854723 | SKD Electrochemical System (Ecs)CEM · Traditional | 03/05/1986SE |
| K852841 | Rapid Direct Strep a Latex Agglutination TestGTZ · Traditional | 07/24/1985SE |
| K821884 | Gastroccult TMKHE · Traditional | 10/08/1982SE |
| K821674 | Spinchem Acid Phosphatase ReagentCKB · Traditional | 06/22/1982SE |
Questions and answers
When was Sigmoidoscope/ Disposable cleared by the FDA?
Sigmoidoscope/ Disposable (K761180) received a 510(k) decision of Substantially Equivalent on January 5, 1977, 34 days after the submission was received.
What is the product code of K761180?
The FDA product code is FAM – Sigmoidoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.