Sigmoidoscope Tipless
FDA 510(k) K790610 · Welch Allyn, Inc.
510(k) numberK790610
Submission
- Device name
- Sigmoidoscope Tipless
- Applicant
- Welch Allyn, Inc.
Walker, MI, US - Received
- March 29, 1979
- Decision date
- April 23, 1979
- 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 |
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| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…MHX · Special | 06/30/2017SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
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Questions and answers
When was Sigmoidoscope Tipless cleared by the FDA?
Sigmoidoscope Tipless (K790610) received a 510(k) decision of Substantially Equivalent on April 23, 1979, 25 days after the submission was received.
What is the product code of K790610?
The FDA product code is FAM – Sigmoidoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.