The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Laparoscopic Inst. (scissors,forceps,needleholder).
| Device ID | K925079 | 
| 510k Number | K925079 | 
| Device Name: | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | 
| Classification | Laparoscope, Gynecologic (and Accessories) | 
| Applicant | ENDO TECHNIC CORP. 3027 COMMERICAL AVE. Northbrook, IL 60062 | 
| Contact | Dan Gudeman | 
| Correspondent | Dan Gudeman ENDO TECHNIC CORP. 3027 COMMERICAL AVE. Northbrook, IL 60062 | 
| Product Code | HET | 
| CFR Regulation Number | 884.1720 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1992-10-07 | 
| Decision Date | 1994-08-24 |