Biopsys Medical, Inc.
San Juan Capistrano, CA, US
Biopsys Medical, Inc. appears in FDA device records in San Juan Capistrano, CA. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Biopsys Medical, Inc. between 1994 and 1997. The busiest year on record is 1994, with 6. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 6 |
| 1995 | 5 |
| 1996 | 2 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K970817 | MICROMARK CLIP | GDW | Substantially Equivalent | |
| K970565 | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) | KNW | Substantially Equivalent | |
| K963015 | SURGICAL STAPLE MARKER DEVICE (MODIFY) | GDW | Substantially Equivalent | |
| K960019 | RETRACTOR ARM CLAMP | FWZ | Substantially Equivalent | |
| K953962 | FORCEPS | GEN | Substantially Equivalent | |
| K953880 | BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K951326 | BIOPSY DEVICE ACCESSORY | BTA | Substantially Equivalent | |
| K951229 | MODIFIED BIOPSY NEEDLE | KNW | Substantially Equivalent | |
| K950006 | SURGICAL STAPLE MARKER | GDW | Substantially Equivalent | |
| K943863 | NEEDLE GUIDE | IYN | Substantially Equivalent | |
| K945573 | BIOPSY DEVICE ACCESSORY | KNW | Substantially Equivalent | |
| K944252 | BIOPSY DEVICE ACCESSORY | FCK | Substantially Equivalent | |
| K945133 | MODIFIED BIOPSY NEEDLE | FCG | Substantially Equivalent | |
| K942639 | BIOPSY NEEDLE AND HOUSING | KNW | Substantially Equivalent | |
| K941549 | BIOPSY NEEDLE AND HOUSING | KNW | 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