Andrew Technologies, LLC FDA Record
Andrew Technologies, LLC has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Andrew Technologies, LLC" is on file.
- Latest inspection
- Sep 16, 2014 · NAI
- Latest 510(k)
- Apr 18, 2013
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 16, 2014 | Tustin, CA | Devices | No Action Indicated (NAI) | 3008517697 |
| Jun 29, 2011 | Tustin, CA | Devices | No Action Indicated (NAI) | 3008517697 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008517697 | Tustin, CA | 2 | Sep 16, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K130152 | HYDRASOLVE LIPOPLASTY SYSTEM | Apr 18, 2013 |
| K121218 | HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE… | Dec 13, 2012 |
| K092066 | PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT… | Apr 12, 2010 |
Andrew Technologies, LLC and the FDA: common questions
Has Andrew Technologies, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Andrew Technologies, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Andrew Technologies, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Andrew Technologies, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Andrew Technologies, LLC?
The most recent FDA inspection on file ended Sep 16, 2014 at Tustin, CA and was classified NAI. FDA has 2 inspections of Andrew Technologies, LLC on file.
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