Panels › Gastroenterology, Urology › Product code GCP · Class 2
Endoscope, Ac-Powered And Accessories
Regulation 876.1500
0510(k)s in 12 months (13 all time)
2recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in GCP
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Corporation of the Americas | 0 | 5 |
| Propper Mfg. Co., Inc. | 3 | 0 |
| American Endoscopy, Inc. | 1 | 0 |
| Endotherapeutics | 1 | 0 |
| Endovations | 1 | 0 |
| Medical Dynamics, Inc. | 1 | 0 |
| North Eos Industries, Inc. | 1 | 0 |
| Olympus Corp. | 1 | 0 |
| Porges Corp. | 1 | 0 |
| Reichert Scientific Instruments | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 1996 | K954614 | EOS BRAND DISPOSABLE PROCTOSCOPE North Eos Industries, Inc., TW | GCP |
| Jan 30, 1990 | K896505 | PORGES UNIVERSAL HANDLES Porges Corp. | GCP |
| Dec 27, 1989 | K896008 | MODEL 6500 MERCURY ARC LIGHT SOURCE Medical Dynamics, Inc. | GCP |
| Sep 22, 1986 | K862424 | STEERABLE CATHETER SYSTEM Endovations | GCP |
| Feb 12, 1986 | K860103 | MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE Endotherapeutics | GCP |
| Jan 18, 1985 | K843683 | MODULAR FIBERSCOPE SYSTEM Reichert Scientific Instruments | GCP |
| Jan 3, 1984 | K833859 | TAMPONADE BALLOON CUFF American Endoscopy, Inc. | GCP |
| Aug 27, 1982 | K821999 | ENDOSCOPIC SCLEROTHERAPY BALLOON Retech | GCP |
| Jul 28, 1980 | K801247 | CCD ENDOSCOPE AND ATTACHMENTS Welch Allyn, Inc. | GCP |
| Apr 2, 1979 | K790071 | ENDOSCOPE AND ACCESSORIES Olympus Corp. | GCP |
| Oct 20, 1977 | K771920 | FIBER OPTICS PROCTOSCOPE Propper Mfg. Co., Inc. | GCP |
| Oct 20, 1977 | K771919 | FIBER OPTICS SIGMOIDOSCOPE Propper Mfg. Co., Inc. | GCP |
| Oct 20, 1977 | K771918 | FIBEO OPTICS ILLUM. SYSTEM Propper Mfg. Co., Inc. | GCP |
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