Laparomed Corp.
Irvine, CA, US
Laparomed Corp. appears in FDA device records in Irvine, CA. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Laparomed Corp. between 1991 and 1994. The busiest year on record is 1991, with 5. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 5 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K934527 | FASCIA STITCHER | GCJ | Substantially Equivalent | |
| K930569 | LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM | GCJ | Substantially Equivalent | |
| K921921 | CATHETER CHOLANGIOGRAPHY | GEI | Substantially Equivalent | |
| K921053 | LAPAROMED LIGATING LOOP | KCJ | Substantially Equivalent | |
| K921006 | LAPAROSCOPIC RETRACTOR SYSTEM | GCS | Substantially Equivalent | |
| K914066 | ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS | GEI | Substantially Equivalent | |
| K910074 | LAPAROMED HOOK/SPATULA DEVICE | GEI | Substantially Equivalent | |
| K910219 | LAPAROMED CHOLANGIOGRAM DEVICE | FGE | Substantially Equivalent | |
| K910218 | LAPAROMED CHOLANGIOGRAM VACUUM DEVICE | GCX | Substantially Equivalent | |
| K905722 | SUTURE APPLIER DEVICE | MFJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain