Data / Medical devices / United States / Mast Biosurgery Usa Inc.
Mast Biosurgery Usa Inc.: FDA-registered device maker in San Diego, CA, United States, 4 510(k) clearances
Mast Biosurgery Usa Inc. is registered with the FDA (registration 3004661493) in San Diego, CA, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 7, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004661493
- Address
- 6749 Top Gun St Ste 108, San Diego, CA, United States, 92121
- Owner or operator
- Mast Biosurgery USA (9064241)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- July 25, 2006
- Registered through
- 2026
- Brand names listed
- CARDIOWRAP, CardioWrap Adhesion Barrier Film, OrthoWrap, OrthoWrap Adhesion Barrier Film, SURGIWRAP, SurgiWrap Adhesion Barrier Film, SurgiWrap FROST, SurgiWrap FROST Adhesion Barrier Film
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Absorbable, Adhesion | MCN | 3 | Manufacturer for export | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Pericardial Patch To Facilitate Revision Surgeries | OMH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 7, 2021 | K200918 | SurgiWrap FROST | FTL | Substantially Equivalent | Mast Biosurgery | accessdata.fda.gov |
| January 16, 2008 | K072190 | ORTHO-WRAP BIORESORBABLE SHEET | FTL | Substantially Equivalent | Mast Biosurgery | accessdata.fda.gov |
| May 27, 2005 | K050332 | SURGI-WRAP MAST BIORESORBABLE SHEET | FTL | Substantially Equivalent | Mast Biosurgery USA, Inc. | accessdata.fda.gov |
| September 4, 2003 | K031785 | MACROPORE CARDIO-WRAP (TS) | OMH | Substantially Equivalent | Macropore Biosurgery, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 26, 2014 | 70051 | Class II | Terminated | The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional | The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date was July 31, 2017. | accessdata.fda.gov |
Compare with other makers
Updated January 7, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.