Sigmoidoscope, Flexible
FDA 510(k) K822765 · Harvard Laboratories
510(k) numberK822765
Submission
- Device name
- Sigmoidoscope, Flexible
- Applicant
- Harvard Laboratories
Walker, MI, US - Received
- September 14, 1982
- Decision date
- November 17, 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 |
|---|---|---|
| K810573 | Tube Feeding SetKNT · Traditional | 04/23/1981SE |
| K810574 | Suction Collection Bottle, DisposableKDQ · Traditional | 04/21/1981SE |
| K800879 | Clear Plastic Connecting TubesFPK · Traditional | 06/17/1980SE |
| K800878 | Secondary I.V. Tubing SetsFPA · Traditional | 06/17/1980SE |
| K800877 | Anesthesia Extension TubesFPK · Traditional | 06/17/1980SE |
| K800880 | Plastic Tubing Adapters 5-IN-1-DTL · Traditional | 05/14/1980SE |
| K800881 | Disposable Berman AirwaysCAE · Traditional | 05/08/1980SE |
Questions and answers
When was Sigmoidoscope, Flexible cleared by the FDA?
Sigmoidoscope, Flexible (K822765) received a 510(k) decision of Substantially Equivalent on November 17, 1982, 64 days after the submission was received.
What is the product code of K822765?
The FDA product code is FAM – Sigmoidoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.