Specialty Surgical Products, Inc.
Victor, MT, US
SPECIALTY SURGICAL PRODUCTS, INC. appears in FDA device records in Victor, MT. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Specialty Surgical Products, Inc. between 1997 and 2014. The busiest year on record is 1998, with 6. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 3 |
| 1998 | 6 |
| 1999 | 2 |
| 2007 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140383 | ALLOX2 TISSUE EXPANDERS | LCJ | Substantially Equivalent | |
| K070303 | SILICONE TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K984106 | MAMMARY SIZER, MAMMARY PROTHESIS SIZER | MRD | Substantially Equivalent | |
| K983015 | VIRILIS PENILE PROSTHESIS | FTQ | Substantially Equivalent | |
| K982258 | MAMMARY SIZER | MRD | Substantially Equivalent | |
| K982065 | STERILE SILICONE EXTERNAL WOUND COVER | MIB | Substantially Equivalent | |
| K982067 | MAGNETIC PORT SILICONE TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K974653 | SILICONE ELASTOMER SHEETING | MIB | Substantially Equivalent | |
| K974654 | SILICONE BLOCKS | MIB | Substantially Equivalent | |
| K974209 | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K973656 | DISPOSABLE SILICONE EPISTAXIS CATHETER | EMX | Substantially Equivalent | |
| K973082 | VENTRAL WALL DEFECT REDUCTION SILO | FTL | Substantially Equivalent | |
| K973114 | SILICONE BILIARY STENT/BILIARY CATHETER | FGE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3031984 | 3001237472 | SPECIALTY SURGICAL PRODUCTS, INC. | 1123 NORTH U.S. HWY. 93, VICTOR, MT 59875 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain