Product code FFQ
- Device name
- Speculum, Rectal
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.4730
- 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 |
|---|---|---|---|
| K851797 | 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH | Artiberia | 1985-05-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B382SD917665110 | Surgical Direct | Surgical Direct, Inc. | 2026-10-20 |
| B382SD917665120 | Surgical Direct | Surgical Direct, Inc. | 2026-10-20 |
| B382SD917665700 | Surgical Direct | Surgical Direct, Inc. | 2026-10-20 |
| B382SD917665920 | Surgical Direct | Surgical Direct, Inc. | 2026-10-20 |
| B382SD917665930 | Surgical Direct | Surgical Direct, Inc. | 2026-10-20 |
| B382SD917665100 | Surgical Direct | Surgical Direct, Inc. | 2026-10-20 |
| 00190776433444 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433505 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433499 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433482 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433475 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433468 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433451 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433437 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433420 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433413 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433406 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433390 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433383 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433376 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433369 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| 00190776433352 | Millennium | Avalign Technologies, Inc. | 2026-10-05 |
| G141554100200 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-09-30 |
| 00190776432362 | Millennium | Avalign Technologies, Inc. | 2026-09-24 |
| 00860015748508 | Thermora Anoscope | OMEC Medical (NV) Inc. | 2026-07-31 |
| 00190776422189 | Millennium | Avalign Technologies, Inc. | 2026-07-28 |
| 00850048720619 | Speculum Kits | Specialty Health Products, LLC | 2026-07-23 |
| 00850048720626 | Speculum Kits | Specialty Health Products, LLC | 2026-07-23 |
| 00850048720633 | Speculum Kits | Specialty Health Products, LLC | 2026-07-23 |
| 00850048720640 | Speculum Kits | Specialty Health Products, LLC | 2026-07-23 |