The following data is part of a premarket notification filed by Greenwald Surgical Co., Inc. with the FDA for Greenwald Control-tip Cystoscopic Electrode.
| Device ID | K933173 |
| 510k Number | K933173 |
| Device Name: | GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | GREENWALD SURGICAL CO., INC. 2688 DEKALB ST. Lake Station, IN 46405 |
| Contact | Christopher Reynolds |
| Correspondent | Christopher Reynolds GREENWALD SURGICAL CO., INC. 2688 DEKALB ST. Lake Station, IN 46405 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-29 |
| Decision Date | 1994-04-01 |