The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Endoscope.
| Device ID | K944555 | 
| 510k Number | K944555 | 
| Device Name: | ENDOSCOPE | 
| Classification | Laparoscope, Gynecologic (and Accessories) | 
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 | 
| Contact | Jonathan Gilbert | 
| Correspondent | Jonathan Gilbert UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 | 
| Product Code | HET | 
| CFR Regulation Number | 884.1720 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1994-09-16 | 
| Decision Date | 1994-12-30 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  ENDOSCOPE  98127497  not registered Live/Pending | CHEN, XIAOFENG 2023-08-10 |