The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Grasper, Dissector, Forceps, Needle Holder.
| Device ID | K942574 |
| 510k Number | K942574 |
| Device Name: | GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1994-09-28 |