Innerdyne, Inc.: FDA clearances and approvals
Innerdyne, Inc. has 12 FDA 510(k) clearances (first 1995, latest 2000), across 4 product codes in 3 review panels. Median 510(k) review time: 87 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 7 | 7 |
| DYB | Introducer, Catheter | 3 | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Innerdyne, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992668 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) | DYB | 2000-05-26 | 291 |
| K990854 | INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE | FGE | 1999-08-02 | 140 |
| K990493 | INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE | GCJ | 1999-05-18 | 90 |
| K982417 | INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP | GCJ | 1998-10-07 | 86 |
| K980578 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) | DYB | 1998-09-11 | 206 |
| K972684 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM | DYB | 1997-10-10 | 85 |
| K971230 | SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT | KNT | 1997-06-13 | 72 |
| K970754 | INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP | GCJ | 1997-04-21 | 49 |
| K961940 | INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP | GCJ | 1996-07-10 | 51 |
| K961430 | INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP | GCJ | 1996-05-28 | 43 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Innerdyne, 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 Innerdyne, Inc. have?
Innerdyne, Inc. has 12 FDA 510(k) clearances (first 1995, latest 2000), across 4 product codes in 3 review panels.
How long does FDA take to clear Innerdyne, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Innerdyne, Inc.'s cleared 510(k)s is 87 days.
What devices does Innerdyne, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 7); DYB (Introducer, Catheter, 3); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Has Innerdyne, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Innerdyne, Inc. Related entities may recall under other names.
Next steps
- See all 12 Innerdyne, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Innerdyne, 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.