The following data is part of a premarket notification filed by Marlo Surgical Technology with the FDA for Gyneguide.
| Device ID | K894591 |
| 510k Number | K894591 |
| Device Name: | GYNEGUIDE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Contact | Scott Marlow |
| Correspondent | Scott Marlow MARLO SURGICAL TECHNOLOGY 1810 JOSEPH LLOYD PKWY. Willoughby, OH 44094 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-10-10 |