Surgipath Medical Industries, Inc.: FDA clearances and approvals
Surgipath Medical Industries, Inc. has 30 FDA 510(k) clearances (first 1977, latest 1988), across 20 product codes in 3 review panels. Median 510(k) review time: 20 days.
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 |
|---|---|---|---|
| IFP | Formalin, Neutral Buffered | 4 | 4 |
| HHT | Spatula, Cervical, Cytological | 3 | 3 |
| KEO | Formulations, Paraffin, All | 3 | 3 |
| IDL | Microtome, Accessories | 2 | 2 |
| IDZ | Cassettes, Tissue | 2 | 2 |
| KER | Container, Embedding | 2 | 2 |
| EMF | Knife, Surgical | 1 | 1 |
| HZT | Reagent, Schiff | 1 | 1 |
| IAB | Toluidine Blue | 1 | 1 |
| IDO | Microtome, Rotary | 1 | 1 |
Plus 10 more product codes.
Review panels
Most recent Surgipath Medical Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K883217 | SCHIFF REAGENT | HZT | 1988-08-05 | 7 |
| K881921 | C-E BRUSH | HHT | 1988-07-19 | 71 |
| K881922 | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | LDZ | 1988-05-25 | 16 |
| K881659 | TISSUE SECTION ADHESIVE | IFZ | 1988-04-21 | 6 |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | EMF | 1986-09-30 | 18 |
| K863616 | KNIFE MAKER | IDL | 1986-09-25 | 9 |
| K863548 | ROTARY MICROTOME | IDO | 1986-09-19 | 7 |
| K863483 | CASSETTE EMBOSSEER | IDZ | 1986-09-16 | 7 |
| K863145 | CERVICAL SCRAPERS | HHT | 1986-08-19 | 4 |
| K861270 | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | KEO | 1986-04-11 | 7 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Surgipath Medical Industries, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Surgipath Medical Industries, Inc. have?
Surgipath Medical Industries, Inc. has 30 FDA 510(k) clearances (first 1977, latest 1988), across 20 product codes in 3 review panels.
How long does FDA take to clear Surgipath Medical Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Surgipath Medical Industries, Inc.'s cleared 510(k)s is 20 days.
What devices does Surgipath Medical Industries, Inc. make?
Its most frequent FDA product codes are IFP (Formalin, Neutral Buffered, 4); HHT (Spatula, Cervical, Cytological, 3); KEO (Formulations, Paraffin, All, 3).
Has Surgipath Medical Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgipath Medical Industries, Inc. Related entities may recall under other names.
Next steps
- See all 30 Surgipath Medical Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IFP, Surgipath Medical Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.