ENDOTACK
Fastener, Fixation, Nondegradable, Soft Tissue
KARL STORZ ENDOSCOPY-AMERICA, INC.
The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Endotack.
Pre-market Notification Details
| Device ID | K022853 |
| 510k Number | K022853 |
| Device Name: | ENDOTACK |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-27 |
| Decision Date | 2002-11-25 |
| Summary: | summary |
Trademark Results [ENDOTACK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOTACK 76290403 3635643 Live/Registered |
KARL STORZ SE & CO. KG 2001-07-25 |
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