Boston Surgical Products, Inc.
Kingston, MA, US
Boston Surgical Products, Inc. appears in FDA device records in Kingston, MA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Boston Surgical Products, Inc. between 1994 and 1997. The busiest year on record is 1994, with 8. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 8 |
| 1995 | 7 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972311 | MODEL 20 BIPOLAR COAGULATOR | GEI | Substantially Equivalent | |
| K972350 | MODEL 50 BIPOLAR COAGULATOR | GEI | Substantially Equivalent | |
| K944947 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS | GEI | Substantially Equivalent | |
| K953012 | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | GFA | Substantially Equivalent | |
| K950375 | DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR | GEI | Substantially Equivalent | |
| K951912 | DISOPOSABLE & RESUABLE MONPOLAR CORD | GEI | Substantially Equivalent | |
| K951269 | DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL | GEI | Substantially Equivalent | |
| K950877 | REUSABLE MONOPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K945171 | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE | KYG | Substantially Equivalent | |
| K945893 | DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE | GEI | Substantially Equivalent | |
| K945717 | ELECTROSURGICAL ENDOSCOPIC CORD | GEI | Substantially Equivalent | |
| K944642 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | GEI | Substantially Equivalent | |
| K944634 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | GEI | Substantially Equivalent | |
| K944578 | BIPOLAR CORD | GEI | Substantially Equivalent | |
| K942710 | DISPOSABLE BIPOLAR COAGULATING FORCEPS | GEI | Substantially Equivalent | |
| K945299 | DISPOSABLE & REUSABLE CHUCK HANDLE | GEI | Substantially Equivalent | |
| K943031 | BIPOLAR ELECTROSURGICAL PENCIL | HQO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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