The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Gleeson Clot-buster.
| Device ID | K920139 |
| 510k Number | K920139 |
| Device Name: | GLEESON CLOT-BUSTER |
| Classification | Laryngoscope, Endoscope |
| Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Contact | Forte, Jr. |
| Correspondent | Forte, Jr. CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
| Product Code | GCI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-13 |
| Decision Date | 1992-04-15 |