The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Percutaneous Endoscopic Gastrostomy.
| Device ID | K924306 |
| 510k Number | K924306 |
| Device Name: | PERCUTANEOUS ENDOSCOPIC GASTROSTOMY |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Contact | Lisa Scholz |
| Correspondent | Lisa Scholz UNITED STATES ENDOSCOPY GROUP, INC. 7123 INDUSTRIAL PARK BLVD. Mentor, OH 44060 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-26 |
| Decision Date | 1995-05-15 |