FDA Product Code
FDA Product Code GCP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1500
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K954614 | EOS BRAND DISPOSABLE PROCTOSCOPE | North Eos Industries, Inc. | 1996-04-10 | Traditional | PDF ↗ |
| K896505 | PORGES UNIVERSAL HANDLES | Porges Corp. | 1990-01-30 | Traditional | PDF ↗ |
| K896008 | MODEL 6500 MERCURY ARC LIGHT SOURCE | Medical Dynamics, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K862424 | STEERABLE CATHETER SYSTEM | Endovations | 1986-09-22 | Traditional | PDF ↗ |
| K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE | Endotherapeutics | 1986-02-12 | Traditional | PDF ↗ |
| K843683 | MODULAR FIBERSCOPE SYSTEM | Reichert Scientific Instruments | 1985-01-18 | Traditional | PDF ↗ |
| K833859 | TAMPONADE BALLOON CUFF | American Endoscopy, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K821999 | ENDOSCOPIC SCLEROTHERAPY BALLOON | Retech | 1982-08-27 | Traditional | PDF ↗ |
| K801247 | CCD ENDOSCOPE AND ATTACHMENTS | Welch Allyn, Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K790071 | ENDOSCOPE AND ACCESSORIES | Olympus Corp. | 1979-04-02 | Traditional | PDF ↗ |
| K771920 | FIBER OPTICS PROCTOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 | Traditional | PDF ↗ |
| K771918 | FIBEO OPTICS ILLUM. SYSTEM | Propper Mfg. Co., Inc. | 1977-10-20 | Traditional | PDF ↗ |
| K771919 | FIBER OPTICS SIGMOIDOSCOPE | Propper Mfg. Co., Inc. | 1977-10-20 | Traditional | PDF ↗ |
Product code GCP · Class II · Gastroenterology, Urology. Data: openFDA.