Innovative Surgical, Inc.
West Palm Beach, FL, US
Innovative Surgical, Inc. appears in FDA device records in West Palm Beach, FL. FDA records list 7 510(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
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Innovative Surgical, Inc. between 1993 and 1995. The busiest year on record is 1993, with 4. The most recent is 1995, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 4 |
| 1994 | 2 |
| 1995 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K945394 | INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER | GCJ | Substantially Equivalent | |
| K932696 | ISI(R) CURVED, TAPERED DISSECTING FORCEPS | GCJ | Substantially Equivalent | |
| K932695 | ISI(R) PORPOISE NOSE DISSECTING FORCEPS | GCJ | Substantially Equivalent | |
| K934075 | ISI METZENBAUM SCISSORS | GEI | Substantially Equivalent | |
| K932697 | ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR | GCJ | Substantially Equivalent | |
| K932698 | ISI(R) HOOK SUTURES SCISSORS | GCJ | Substantially Equivalent | |
| K932534 | ISI FENESTRATED DISSECTING AND GRASPING FORCEPS | GFI | 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