MAST Biosurgery USA, Inc
San Diego, CA, US
MAST BIOSURGERY USA INC. appears in FDA device records in San Diego, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for MAST Biosurgery USA, Inc between 2005 and 2010. The busiest year on record is 2005, with 1. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090637 | CARDIO-WRAP | DXZ | Unknown | |
| K063648 | SURGI-WRAP MAST TENDON SHEET | FTL | Substantially Equivalent | |
| K061473 | SURGI-WRAP MAST BIORESORBABLE SHEET | FTL | Substantially Equivalent | |
| K050332 | SURGI-WRAP MAST BIORESORBABLE SHEET | FTL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004661493 | 3004661493 | MAST BIOSURGERY USA INC. | 6749 Top Gun St Ste 108, SAN DIEGO, CA 92121 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1076-2015 | 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 envelope. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain