The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Draw Tight 1.8mm Single-loaded Suture Anchor.
| Device ID | K122805 |
| 510k Number | K122805 |
| Device Name: | PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay, WI 54235 |
| Contact | Paul Vagts |
| Correspondent | Paul Vagts PARCUS MEDICAL, LLC 839 SOUTH NEENAH AVE. Sturgeon Bay, WI 54235 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-13 |
| Decision Date | 2013-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M685105880 | K122805 | 000 |
| 00816342024112 | K122805 | 000 |
| 00816342024372 | K122805 | 000 |
| 00816342024389 | K122805 | 000 |
| 00816342021555 | K122805 | 000 |
| 00816342021975 | K122805 | 000 |
| 00816342021548 | K122805 | 000 |
| 00816342021562 | K122805 | 000 |
| 00816342024099 | K122805 | 000 |
| M685112880 | K122805 | 000 |
| M685112890 | K122805 | 000 |
| M685112970 | K122805 | 000 |
| M685105650 | K122805 | 000 |
| 00816342024105 | K122805 | 000 |