I.C. Medical, Inc.
Phoenix, AZ, US
I.C. MEDICAL, INC. appears in FDA device records in Phoenix, AZ. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for I.C. Medical, Inc. between 1990 and 2017. The busiest year on record is 1996, with 4. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 4 |
| 2001 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K163659 | Crystal Vision | FYD | Substantially Equivalent | |
| K160160 | Non-Telescopic PenEvac | GEI | Substantially Equivalent | |
| K003840 | CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES | FYD | Substantially Equivalent | |
| K960492 | SI CONTROLLER MODEL SI 500 | BTA | Substantially Equivalent | |
| K961616 | TELESCOPING PENEVAC (MODIFICATION) | GEI | Substantially Equivalent | |
| K955166 | PENEVAC SI. | GEI | Substantially Equivalent | |
| K955020 | PENEVAC ABC HANDPIECE | GEI | Substantially Equivalent | |
| K953418 | ELECTROCAUTERY SHROUD | GCJ | Substantially Equivalent | |
| K954088 | TELESCOPING PENEVAC | GEI | Substantially Equivalent | |
| K932230 | CRYSTAL VISION AND ACCESSORIES | FYD | Substantially Equivalent | |
| K930099 | LASER HANDPIECE SHROUD | GEX | Substantially Equivalent | |
| K930098 | SPECULUM SMOKE EVACUATOR TUBING | GEX | Substantially Equivalent | |
| K930097 | ELECTROCAUTERY SHROUD | GEI | Substantially Equivalent | |
| K914118 | I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR | FYD | Substantially Equivalent | |
| K902611 | I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR | FYD | Substantially Equivalent | |
| K900511 | I.C. MEDICAL ADJUSTABLE DIRECT COUPLER | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008805497 | 3008805497 | I.C. MEDICAL, INC. | 15002 N. 25th Dr., Phoenix, AZ 85023 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
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