Product code GCP
- Device name
- Endoscope, Ac-Powered And Accessories
- 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 |
|---|---|---|---|
| K954614 | EOS BRAND DISPOSABLE PROCTOSCOPE | North Eos Industries, Inc. | 1996-04-10 |
| K896505 | PORGES UNIVERSAL HANDLES | Porges Corp. | 1990-01-30 |
| K896008 | MODEL 6500 MERCURY ARC LIGHT SOURCE | Medical Dynamics, Inc. | 1989-12-27 |
| K862424 | STEERABLE CATHETER SYSTEM | Endovations | 1986-09-22 |
| K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | Endotherapeutics | 1986-02-12 |
| K843683 | MODULAR FIBERSCOPE SYSTEM | Reichert Scientific Instruments | 1985-01-18 |
| K833859 | TAMPONADE BALLOON CUFF | American Endoscopy, Inc. | 1984-01-03 |
| K821999 | ENDOSCOPIC SCLEROTHERAPY BALLOON | Retech | 1982-08-27 |
| K801247 | CCD ENDOSCOPE AND ATTACHMENTS | Welch Allyn, Inc. | 1980-07-28 |
| K790071 | ENDOSCOPE AND ACCESSORIES | Olympus Corp. | 1979-04-02 |
| K771918 | FIBEO OPTICS ILLUM. SYSTEM | Propper Mfg. Co., Inc. | 1977-10-20 |
| K771919 | FIBER OPTICS SIGMOIDOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 |
| K771920 | FIBER OPTICS PROCTOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033737710029 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710425 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710418 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710401 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710395 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710388 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710364 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710340 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710333 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710203 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710197 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710180 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710173 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710166 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710159 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710142 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710135 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710128 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710111 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710104 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710098 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710081 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710074 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710067 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710050 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710043 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710036 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710012 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-12-23 |
| 08033737710432 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-10-07 |
| 08033737710449 | THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope | THD SPA | 2016-10-07 |