Laparomed Corp.: FDA clearances and approvals
Laparomed Corp. has 10 FDA 510(k) clearances (first 1991, latest 1994), across 7 product codes in 4 review panels. Median 510(k) review time: 102 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 | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| GCS | Endoscope, Battery-Powered And Accessories | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| KCJ | Applicator, Ent | 1 | 1 |
| MFJ | Device, Endoscopic Suturing | 1 | 1 |
Review panels
- General and Plastic Surgery (6)
- Gastroenterology and Urology (2)
- Ear, Nose and Throat (1)
- General Hospital (1)
Most recent Laparomed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934527 | FASCIA STITCHER | GCJ | 1994-02-25 | 158 |
| K930569 | LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM | GCJ | 1993-04-20 | 89 |
| K921921 | CATHETER CHOLANGIOGRAPHY | GEI | 1992-08-17 | 116 |
| K921053 | LAPAROMED LIGATING LOOP | KCJ | 1992-08-06 | 154 |
| K921006 | LAPAROSCOPIC RETRACTOR SYSTEM | GCS | 1992-07-28 | 147 |
| K914066 | ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS | GEI | 1991-11-07 | 57 |
| K910074 | LAPAROMED HOOK/SPATULA DEVICE | GEI | 1991-07-02 | 175 |
| K910219 | LAPAROMED CHOLANGIOGRAM DEVICE | FGE | 1991-04-08 | 81 |
| K910218 | LAPAROMED CHOLANGIOGRAM VACUUM DEVICE | GCX | 1991-04-08 | 81 |
| K905722 | SUTURE APPLIER DEVICE | MFJ | 1991-03-14 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Laparomed Corp..
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 Laparomed Corp. have?
Laparomed Corp. has 10 FDA 510(k) clearances (first 1991, latest 1994), across 7 product codes in 4 review panels.
How long does FDA take to clear Laparomed Corp.'s 510(k)s?
The median time from FDA receipt to decision across Laparomed Corp.'s cleared 510(k)s is 102 days.
What devices does Laparomed Corp. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); GCJ (Laparoscope, General & Plastic Surgery, 2); FGE (Stents, Drains And Dilators For The Biliary Ducts, 1).
Has Laparomed Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Laparomed Corp. Related entities may recall under other names.
Next steps
- See all 10 Laparomed Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Laparomed Corp.'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.