The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Adapt Balloon Open Access Port, Model 41244.
| Device ID | K023261 |
| 510k Number | K023261 |
| Device Name: | ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Contact | Max Cloat |
| Correspondent | Max Cloat TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2002-12-13 |