FS-34P2, Fiber Sigmoidoscope
FDA 510(k) K951576 · Pentax Precision Instrument Corp.
510(k) numberK951576
Submission
- Device name
- FS-34P2, Fiber Sigmoidoscope
- Applicant
- Pentax Precision Instrument Corp.
Miramar, FL, US - Received
- April 4, 1995
- Decision date
- June 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K951573 | FS-38H, Fiber SigmoidoscopeFAM · Traditional | Pentax Precision Instrument Corp. | 06/27/1995SE |
| K951572 | FS-38X, Fiber SigmoidoscopeFAM · Traditional | Pentax Precision Instrument Corp. | 06/27/1995SE |
More from Pentax Precision Instrument Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K041397 | EG-3830UTITX · Traditional | 06/09/2004SE |
| K041396 | FG-36UX Fiber Ultrasound GastroscopeITX · Traditional | 06/09/2004SE |
| K041395 | EG-3630URITX · Traditional | 06/09/2004SE |
| K031789 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 08/08/2003SE |
| K023401 | EG-3830UT, Video Ultrasound GastroscopeODG · Traditional | 02/11/2003SE |
| K023376 | EB-1830T3, Video BronchoscopeEOQ · Special | 10/16/2002SE |
| K021276 | FG-36UX Fiber Ultrasound GastroscopeODG · Traditional | 09/12/2002SE |
| K021278 | EG-3630UR, Ultrasound Video GastroscopeODG · Traditional | 09/06/2002SE |
| K013640 | EG-3630UR, Ultrasund Video GastroscopeFDS · Traditional | 02/04/2002SE |
| K010740 | FG-36UX, Fiber Ultrasound GastroscopeODG · Traditional | 04/17/2001SE |
Questions and answers
When was FS-34P2, Fiber Sigmoidoscope cleared by the FDA?
FS-34P2, Fiber Sigmoidoscope (K951576) received a 510(k) decision of Substantially Equivalent on June 29, 1995, 86 days after the submission was received.
What is the product code of K951576?
The FDA product code is FAM – Sigmoidoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.