The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Coaxial Needle.
| Device ID | K971842 |
| 510k Number | K971842 |
| Device Name: | COAXIAL NEEDLE |
| Classification | Biopsy Needle |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Gretchen Y Cohen |
| Correspondent | Gretchen Y Cohen UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1997-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765012670 | K971842 | 000 |
| 10724995180895 | K971842 | 000 |
| 10724995180901 | K971842 | 000 |
| 10724995180918 | K971842 | 000 |
| 10724995180925 | K971842 | 000 |
| 10724995180932 | K971842 | 000 |
| 10724995180949 | K971842 | 000 |
| 10724995180833 | K971842 | 000 |
| 10724995180840 | K971842 | 000 |
| 10724995180857 | K971842 | 000 |
| 10724995180864 | K971842 | 000 |
| 10724995180871 | K971842 | 000 |
| 10816765011895 | K971842 | 000 |
| 10816765011901 | K971842 | 000 |
| 10816765011918 | K971842 | 000 |
| 10816765011925 | K971842 | 000 |
| 10816765012472 | K971842 | 000 |
| 10816765012663 | K971842 | 000 |
| 10724995180888 | K971842 | 000 |