The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Sialoendoscopes And Accessories.
| Device ID | K012527 |
| 510k Number | K012527 |
| Device Name: | KSEA SIALOENDOSCOPES AND ACCESSORIES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | James A Lee |
| Correspondent | James A Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551196502 | K012527 | 000 |
| 04048551196595 | K012527 | 000 |
| 04048551196588 | K012527 | 000 |
| 04048551196571 | K012527 | 000 |
| 04048551196564 | K012527 | 000 |
| 04048551196557 | K012527 | 000 |
| 04048551196540 | K012527 | 000 |
| 04048551196533 | K012527 | 000 |
| 04048551196526 | K012527 | 000 |
| 04048551196601 | K012527 | 000 |
| 04048551196618 | K012527 | 000 |
| 04048551051009 | K012527 | 000 |
| 04048551051894 | K012527 | 000 |
| 04048551051887 | K012527 | 000 |
| 04048551051740 | K012527 | 000 |
| 04048551051733 | K012527 | 000 |
| 04048551051658 | K012527 | 000 |
| 04048551051641 | K012527 | 000 |
| 04048551051535 | K012527 | 000 |
| 04048551051528 | K012527 | 000 |
| 04048551196519 | K012527 | 000 |