The following data is part of a premarket notification filed by Endooptiks, Inc. with the FDA for Endoprobes.
| Device ID | K922917 |
| 510k Number | K922917 |
| Device Name: | ENDOPROBES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ENDOOPTIKS, INC. 28 MARIGOLD LN. Marlboro, NJ 07746 |
| Contact | Martin S Knopf |
| Correspondent | Martin S Knopf ENDOOPTIKS, INC. 28 MARIGOLD LN. Marlboro, NJ 07746 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-17 |
| Decision Date | 1992-09-28 |