Innervision, Inc.: FDA clearances and approvals
Innervision, Inc. has 6 FDA 510(k) clearances (first 1994, latest 1999), across 4 product codes in 3 review panels. Median 510(k) review time: 122 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| JDS | Nail, Fixation, Bone | 1 | 1 |
Review panels
Most recent Innervision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992345 | CHRISTOUDIAS SLIM TIP ELECTRODE INSERT | GEI | 1999-09-10 | 89 |
| K991877 | MACMED PAEDIATRIC INTRAMEDULLARY NAIL | JDS | 1999-08-06 | 65 |
| K982428 | CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) | HET | 1998-10-09 | 88 |
| K940731 | INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES | GCJ | 1994-09-13 | 207 |
| K940750 | INNERVISION,INC. LAPAROSCOPIC ELECTRODES | GEI | 1994-08-23 | 186 |
| K940718 | INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS | HET | 1994-07-22 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named Innervision, 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 Innervision, Inc. have?
Innervision, Inc. has 6 FDA 510(k) clearances (first 1994, latest 1999), across 4 product codes in 3 review panels.
How long does FDA take to clear Innervision, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Innervision, Inc.'s cleared 510(k)s is 122 days.
What devices does Innervision, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HET (Laparoscope, Gynecologic (And Accessories), 2); GCJ (Laparoscope, General & Plastic Surgery, 1).
Has Innervision, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Innervision, Inc. Related entities may recall under other names.
Next steps
- See all 6 Innervision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Innervision, 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.