Sil-Med Corp.: FDA clearances and approvals
Sil-Med Corp. has 29 FDA 510(k) clearances (first 1980, latest 1997), across 17 product codes in 5 review panels. Median 510(k) review time: 73 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 |
|---|---|---|---|
| GBX | Catheter, Irrigation | 5 | 5 |
| GBW | Catheter, Peritoneal | 4 | 4 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 3 | 3 |
| GBS | Catheter, Ventricular, General & Plastic Surgery | 2 | 2 |
| GCD | Connector, Catheter | 2 | 2 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 | 2 |
| DXC | Clamp, Vascular | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| GAH | Stylet, Surgical, General & Plastic Surgery | 1 | 1 |
| GBC | Lamp, Surgical, Incandescent | 1 | 1 |
Plus 7 more product codes.
Review panels
- General and Plastic Surgery (21)
- Gastroenterology and Urology (3)
- General Hospital (3)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
Most recent Sil-Med Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972521 | NAVIGATOR (STYLET) 2006 | GAH | 1997-10-01 | 86 |
| K961392 | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | FJS | 1997-07-18 | 463 |
| K961194 | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | GBW | 1996-08-08 | 134 |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | GBX | 1996-06-26 | 83 |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | GCY | 1996-03-11 | 60 |
| K955463 | GRIP-A-BOOTS | LXZ | 1996-01-23 | 55 |
| K942709 | MEDIASTINAL SILICONE DRAINS | GBW | 1996-01-04 | 575 |
| K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN | GBX | 1995-05-24 | 876 |
| K926495 | SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE | GBX | 1994-02-02 | 400 |
| K926408 | SIL-SLIP FLAT SUCTION DRAIN | GBX | 1994-02-02 | 408 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sil-Med Corp..
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 Sil-Med Corp. have?
Sil-Med Corp. has 29 FDA 510(k) clearances (first 1980, latest 1997), across 17 product codes in 5 review panels.
How long does FDA take to clear Sil-Med Corp.'s 510(k)s?
The median time from FDA receipt to decision across Sil-Med Corp.'s cleared 510(k)s is 73 days.
What devices does Sil-Med Corp. make?
Its most frequent FDA product codes are GBX (Catheter, Irrigation, 5); GBW (Catheter, Peritoneal, 4); FJS (Catheter, Peritoneal, Long-Term Indwelling, 3).
Has Sil-Med Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sil-Med Corp. Related entities may recall under other names.
Next steps
- See all 29 Sil-Med Corp. clearances with predicates and recalls
- Run predicate analysis for product code GBX, Sil-Med Corp.'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.