Innerdyne Medical, Inc.: FDA clearances and approvals
Innerdyne Medical, Inc. has 6 FDA 510(k) clearances (first 1993, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time: 96 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 | 5 | 5 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
Most recent Innerdyne Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943253 | INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P. | GCJ | 1994-10-11 | 97 |
| K943056 | SINGLE STICK RADIALLY EXPANDING DILATOR | GCJ | 1994-09-27 | 92 |
| K940428 | INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR | GCJ | 1994-04-25 | 84 |
| K940232 | INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P. | GCJ | 1994-04-18 | 94 |
| K932692 | INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT | GCJ | 1993-12-27 | 207 |
| K931489 | INTHERM RADIALLY EXPANDING DILATING INTRODUCER | DYB | 1993-10-15 | 204 |
Recalls
openFDA lists no recalls under a recalling firm named Innerdyne Medical, 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 Medical, Inc. have?
Innerdyne Medical, Inc. has 6 FDA 510(k) clearances (first 1993, latest 1994), across 2 product codes in 2 review panels.
How long does FDA take to clear Innerdyne Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Innerdyne Medical, Inc.'s cleared 510(k)s is 96 days.
What devices does Innerdyne Medical, Inc. make?
Its most frequent FDA product codes are GCJ (Laparoscope, General & Plastic Surgery, 5); DYB (Introducer, Catheter, 1).
Has Innerdyne Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Innerdyne Medical, Inc. Related entities may recall under other names.
Next steps
- See all 6 Innerdyne Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Innerdyne Medical, 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.