Medsurg Industries, Inc.: FDA clearances and approvals
Medsurg Industries, Inc. has 41 FDA 510(k) clearances (first 1982, latest 1994), across 24 product codes in 6 review panels. Median 510(k) review time: 82 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | 5 | 5 |
| LRO | General Surgery Tray | 3 | 3 |
| DQR | Cannula, Catheter | 2 | 2 |
| DRC | Trocar | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| GAA | Needle, Aspiration And Injection, Disposable | 2 | 2 |
| KNW | Instrument, Biopsy | 2 | 2 |
| LFJ | Catheter, Subclavian | 2 | 2 |
| DWO | Needle, Biopsy, Cardiovascular | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
Plus 14 more product codes.
Review panels
- General and Plastic Surgery (13)
- Cardiovascular (7)
- Anesthesiology (5)
- Gastroenterology and Urology (5)
- General Hospital (3)
- Obstetrics and Gynecology (2)
Most recent Medsurg Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920780 | MEDSURG INSERTION TRAY | LFJ | 1994-08-19 | 911 |
| K940175 | MEDSURG STERILE O.R. TOWELS | KKX | 1994-05-26 | 135 |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | FMP | 1994-03-28 | 180 |
| K925558 | INFILTUBE | HIF | 1994-03-04 | 486 |
| K934971 | STERILE LAPAROTOMY SPONGES | GDY | 1994-02-07 | 112 |
| K920421 | MEDSURG MARSHMALLOW TRAY | GAT | 1993-12-13 | 682 |
| K920838 | MEDSURG CIRCUMCISION TRAY | HFK | 1993-10-15 | 599 |
| K931932 | DRESSING CHANGE TRAY-MODIFIED | MCY | 1993-08-27 | 130 |
| K914037 | MEDSURG O.R. PROCEDURE TRAY | LRO | 1993-06-22 | 651 |
| K914036 | MEDSURG LAPAROSCOPY TRAY | LRO | 1992-03-18 | 190 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medsurg 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 Medsurg Industries, Inc. have?
Medsurg Industries, Inc. has 41 FDA 510(k) clearances (first 1982, latest 1994), across 24 product codes in 6 review panels.
How long does FDA take to clear Medsurg Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medsurg Industries, Inc.'s cleared 510(k)s is 82 days.
What devices does Medsurg Industries, Inc. make?
Its most frequent FDA product codes are CAZ (Anesthesia Conduction Kit, 5); LRO (General Surgery Tray, 3); DQR (Cannula, Catheter, 2).
Has Medsurg Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medsurg Industries, Inc. Related entities may recall under other names.
Next steps
- See all 41 Medsurg Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAZ, Medsurg 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.