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 |
|---|---|---|---|
| 00850014947019 | QMS - 48CFST | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947156 | QMS - 42CFHY | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947149 | QMS - 42SBHY | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947132 | QMS - 42CFOP | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947125 | QMS - 42SBOP | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947118 | QMS - 42CFSP | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947101 | QMS - 42SBSP | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947095 | QMS - 42CFST | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947071 | QMS - 48CFHY | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947064 | QMS - 48SBHY | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947057 | QMS - 48CFOP | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947040 | QMS - 48SBOP | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947033 | QMS - 48CFSP | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947026 | QMS - 48SBSP | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947002 | QMS - 48SBST | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 00850014947088 | QMS - 42SBST | QUALITY MEDICAL SUPPLY, INC. | 2019-12-12 |
| 10381780394259 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-09 |
| 10381780394235 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-09 |
| 10381780201373 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-10-31 |
| 10381780201366 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780201380 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780201397 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780201403 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780201410 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780201427 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780394228 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780167037 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780167020 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780394266 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |
| 10381780394273 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-05-16 |