The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Laparoscopic Instruments.
| Device ID | K925114 | 
| 510k Number | K925114 | 
| Device Name: | LAPAROSCOPIC INSTRUMENTS | 
| Classification | Coagulator, Culdoscopic (and Accessories) | 
| Applicant | ENDO TECHNIC CORP. 3027 COMMERICAL AVE. Northbrook, IL 60062 | 
| Contact | Dam Gudeman | 
| Correspondent | Dam Gudeman ENDO TECHNIC CORP. 3027 COMMERICAL AVE. Northbrook, IL 60062 | 
| Product Code | HFI | 
| CFR Regulation Number | 884.4160 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1992-10-09 | 
| Decision Date | 1994-02-28 |