The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Manhes Take-apart Bipolar Coagulating Forceps.
| Device ID | K010345 |
| 510k Number | K010345 |
| Device Name: | KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-05 |
| Decision Date | 2001-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551102114 | K010345 | 000 |
| 04048551102091 | K010345 | 000 |
| 04048551256695 | K010345 | 000 |
| 04048551256688 | K010345 | 000 |
| 04048551256633 | K010345 | 000 |