Biopsys Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Biopsys Medical, Inc.” (first 1994, latest 1997), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 38 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 6 | 6 |
| GDW | Staple, Implantable | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| FCG | Biopsy Needle | 1 | 1 |
| FCK | Instrument, Biopsy, Suction | 1 | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
Most recent Biopsys Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970817 | MICROMARK CLIP | GDW | 1997-09-11 | 189 |
| K970565 | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) | KNW | 1997-03-28 | 43 |
| K963015 | SURGICAL STAPLE MARKER DEVICE (MODIFY) | GDW | 1996-10-07 | 74 |
| K960019 | RETRACTOR ARM CLAMP | FWZ | 1996-02-09 | 38 |
| K953962 | FORCEPS | GEN | 1995-09-08 | 17 |
| K953880 | BIOPSY NEEDLE | KNW | 1995-09-08 | 21 |
| K951326 | BIOPSY DEVICE ACCESSORY | BTA | 1995-05-15 | 53 |
| K951229 | MODIFIED BIOPSY NEEDLE | KNW | 1995-04-06 | 17 |
| K950006 | SURGICAL STAPLE MARKER | GDW | 1995-03-15 | 71 |
| K943863 | NEEDLE GUIDE | IYN | 1994-12-29 | 143 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biopsys Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biopsys Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Biopsys Medical, Inc.” (first 1994, latest 1997), across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biopsys Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biopsys Medical, Inc. is 38 days.
Which FDA product codes appear under Biopsys Medical, Inc.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 6); GDW (Staple, Implantable, 3); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 15 Biopsys Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Biopsys Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.