Flexible Proctosigmoidoscope, #FPS-3
FDA 510(k) K820790 · American Optical Corp.
510(k) numberK820790
Submission
- Device name
- Flexible Proctosigmoidoscope, #FPS-3
- Applicant
- American Optical Corp.
Mchenry, IL, US - Received
- March 23, 1982
- Decision date
- April 1, 1982
- 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 |
|---|---|---|
| K950881 | Phaco TipHQC · Traditional | 09/06/1995SE |
| K950880 | Aoi Universal Ultrasonic HandpieceHQC · Traditional | 05/26/1995SE |
| K931358 | AORP4000 Reusable PakHQC · Traditional | 02/22/1994SE |
| K931354 | P4000 PhacoemulsifierHQC · Traditional | 02/22/1994SE |
| K931357 | AOD4000 Disposable PakHQC · Traditional | 01/25/1994SE |
| K813430 | Tissue Processing Cassettes & AccessIDL · Traditional | 12/29/1981SE |
| K812965 | Model SC-6, Flexible SiamoidoscopeFAM · Traditional | 11/02/1981SE |
| K812051 | Photolite Aolite Tintomatic LensHQG · Traditional | 09/08/1981SE |
| K812063 | SR-1V Data PrinterHKO · Traditional | 08/18/1981SE |
| K811535 | Model FUS-1, Flexible UreteroscopeFGB · Traditional | 06/23/1981SE |
Questions and answers
When was Flexible Proctosigmoidoscope, #FPS-3 cleared by the FDA?
Flexible Proctosigmoidoscope, #FPS-3 (K820790) received a 510(k) decision of Substantially Equivalent on April 1, 1982, 9 days after the submission was received.
What is the product code of K820790?
The FDA product code is FAM – Sigmoidoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.