Gabriel Medical, Inc.
Irvine, CA, US
Gabriel Medical, Inc. appears in FDA device records in Irvine, CA. FDA records list 5 510(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
- 5
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 5 510(k) clearances for Gabriel Medical, Inc. between 1990 and 1996. The busiest year on record is 1994, with 2. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960173 | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT | FAT | Substantially Equivalent | |
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | FCS | Substantially Equivalent | |
| K945297 | INFRA VISION IMAGING SYSTEM | GCJ | Substantially Equivalent | |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | FCS | Substantially Equivalent | |
| K901385 | GABRIEL MEDICAL CLS THERMAL RECORDER | DSF | 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