Gabris Surgical Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Gabris Surgical Corp.” (first 1993, latest 1996), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| FBQ | Trocar, Gastro-Urology | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| HFO | Recorder, Pressure, Intrauterine | 1 | 1 |
Review panels
Most recent Gabris Surgical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954774 | SHIELDED TROCAR (OBTURATOR) | HET | 1996-06-07 | 234 |
| K953548 | LAPAROSCOPIC SURGICAL INSTRUMENT | HET | 1995-09-19 | 53 |
| K944640 | LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT | FBQ | 1994-10-11 | 20 |
| K944104 | GABRIS LAPAROSCOPIC SURGICAL KITS | FBQ | 1994-09-13 | 21 |
| K944103 | LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT | GCJ | 1994-09-12 | 20 |
| K943989 | LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT | HFO | 1994-09-12 | 27 |
| K930716 | LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION | GCJ | 1993-07-23 | 162 |
Recalls
openFDA lists no recalls under a recalling firm named Gabris Surgical Corp..
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 Gabris Surgical Corp.?
FDA lists 7 510(k) clearances under the applicant name “Gabris Surgical Corp.” (first 1993, latest 1996), across 4 product codes in 2 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 Gabris Surgical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gabris Surgical Corp. is 27 days.
Which FDA product codes appear under Gabris Surgical Corp.?
The most frequent FDA product codes under this applicant name are FBQ (Trocar, Gastro-Urology, 2); GCJ (Laparoscope, General & Plastic Surgery, 2); HET (Laparoscope, Gynecologic (And Accessories), 2).
Next steps
- See all 7 Gabris Surgical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FBQ, Gabris Surgical Corp.'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.