The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Percutaneous Foraminoscopy Set.
| Device ID | K001918 |
| 510k Number | K001918 |
| Device Name: | KSEA PERCUTANEOUS FORAMINOSCOPY SET |
| Classification | Arthroscope |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-23 |
| Decision Date | 2000-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551101797 | K001918 | 000 |
| 04048551101674 | K001918 | 000 |
| 04048551098646 | K001918 | 000 |
| 04048551256435 | K001918 | 000 |