Dexide, Inc.: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Dexide, Inc.” (first 1978, latest 1999), across 14 product codes in 3 review panels. Median 510(k) review time under this name: 42 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 11 | 11 |
| GEC | Brush, Scrub, Operating-Room | 10 | 10 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| HIF | Insufflator, Laparoscopic | 2 | 2 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | 2 | 2 |
| FRL | Fiber, Medical, Absorbent | 1 | 1 |
| GCI | Laryngoscope, Endoscope | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HIG | Insufflator, Hysteroscopic | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent Dexide, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991814 | MULTACHOICE INSTRUMENTS | GEI | 1999-06-23 | 27 |
| K990379 | MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES | GCJ | 1999-03-04 | 24 |
| K981940 | MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES | GCJ | 1998-09-25 | 115 |
| K981941 | MULTAPORT CANNULA REDUCER AND ACCESSORIES | GCJ | 1998-07-29 | 57 |
| K953611 | DEXIDE ENDO-LUBE KIT | GCJ | 1995-09-15 | 44 |
| K944509 | DEXIDE INSUFFLATION TUBING WITH FILTER | HIF | 1995-02-07 | 145 |
| K924117 | DEXIDE LAPAROSCOPIC KITS | KDD | 1993-03-23 | 221 |
| K923845 | DEXIDE LAPAROSCOPIC ACCESSORIES | GEI | 1992-11-25 | 117 |
| K921709 | ENDOBAG, MODIFICATION | GCJ | 1992-07-14 | 126 |
| K913762 | MONOSCOPY(TM) BRAND, ENDOBAG | GCJ | 1991-10-28 | 67 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dexide, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dexide, Inc.?
FDA lists 38 510(k) clearances under the applicant name “Dexide, Inc.” (first 1978, latest 1999), across 14 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dexide, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dexide, Inc. is 42 days.
Which FDA product codes appear under Dexide, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 11); GEC (Brush, Scrub, Operating-Room, 10); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3).
Next steps
- See all 38 Dexide, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Dexide, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.