Product code KDM
- Device name
- Sigmoidoscope, Rigid, Non-Electrical
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K070915 | SAPIMED DISPOSABLE SIGMOIDOSCOPE | Sapimed S.P.A. | 2007-07-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033638800614 | Rectoscope equipment | SAPI MED SPA | 2025-02-17 |
| 08033638800621 | Rectoscope equipment | SAPI MED SPA | 2025-02-17 |
| 08033638801536 | Rectoscope equipment | SAPI MED SPA | 2025-02-17 |
| 08033638801567 | Rectoscope equipment | SAPI MED SPA | 2023-07-27 |
| 08033638800720 | Rectoscope equipment | SAPI MED SPA | 2023-07-27 |
| 08033638800713 | Rectoscope equipment | SAPI MED SPA | 2023-07-27 |
| 08033638801550 | Rectoscope equipment | SAPI MED SPA | 2023-07-27 |
| 08033638800225 | Grip for rectoscope | SAPI MED SPA | 2016-11-30 |
| 08033638800188 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800270 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800256 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800218 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800171 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800263 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800249 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800201 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800164 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 08033638800195 | Rectoscope | SAPI MED SPA | 2016-11-25 |
| 00732094080650 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080919 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080902 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080698 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080681 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080674 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080667 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080643 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080636 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00732094080629 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2016-09-17 |
| 00613970014856 | MONARCH DISPOSABLE ANOSCOPE | MONARCH MOLDING, INC. | 2016-09-14 |
| 00613970018908 | MONARCH DISPOSABLE ANOSCOPE | MONARCH MOLDING, INC. | 2016-09-14 |