Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope
FDA 510(k) K963344 · Vision-Sciences, Inc.
510(k) numberK963344
Submission
- Device name
- Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope
- Applicant
- Vision-Sciences, Inc.
Natick, MA, US - Received
- August 26, 1996
- Decision date
- November 21, 1996
- 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 |
| 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 |
| K951572 | FS-38X, Fiber SigmoidoscopeFAM · Traditional | Pentax Precision Instrument Corp. | 06/27/1995SE |
More from Pentax Precision Instrument Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K102733 | Vision-Sciences ENT-5000 Video ENT Scope with Endosheath Technology, Vision-Sciences…EOB · Traditional | 05/18/2011SE |
| K100125 | Vision Sciences Flexible ENT ScopeEOB · Special | 02/25/2010SE |
| K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, DPU-5000/DPU-5050…EOQ · Traditional | 08/03/2009SE |
| K072180 | Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemFAJ · Traditional | 12/18/2007SE |
| K071127 | Flexible Hysteroscope with Endosheath SystemHIH · Traditional | 11/16/2007SE |
| K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…EOX · Special | 08/29/2007SE |
| K072073 | Vision-Sciences ENT-5000 and ENT-5100 Video ENT Scope with Endosheath System…EOB · Special | 08/29/2007SE |
| K071903 | Endosheath Systems for Use with Vision-Sciences Tne ScopeEOX · Special | 08/02/2007SE |
| K053560 | Modified Endosheath System for Vsi Flexible CystoscopeFAJ · Special | 03/16/2006SE |
| K050972 | Vision-Sciences ENT-3000 ScopeEOB · Special | 04/29/2005SE |
Questions and answers
When was Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope cleared by the FDA?
Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope (K963344) received a 510(k) decision of Substantially Equivalent on November 21, 1996, 87 days after the submission was received.
What is the product code of K963344?
The FDA product code is FAM – Sigmoidoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.