Research Instruments Ltd
Falmouth Cornwall, GB
Research Instruments Ltd appears in FDA device records in Falmouth Cornwall, GB. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Research Instruments Ltd carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- RESEARCH INSTRUMENTS LTD - SITE Benforcement report, recall
510(k) clearance history
FDA records hold 9 510(k) clearances for Research Instruments Ltd between 1999 and 2017. The busiest year on record is 1999, with 1. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | MQH | Substantially Equivalent | |
| K160504 | RI Witness Embryology Heated Plate | MQG | Substantially Equivalent | |
| K141434 | SATURN 5 LASER | MRX | Substantially Equivalent | |
| K133257 | BIOPSY PIPETTES | MQH | Substantially Equivalent | |
| K112413 | RI MSC (MIGRATION SEDIMENTATION CHAMBER) | MQK | Substantially Equivalent | |
| K083208 | SATURN ACTIVE LASER SYSTEM | MRX | Substantially Equivalent | |
| K060764 | SATURN 3 LASER SYSTEM | MRX | Substantially Equivalent | |
| K003142 | MICROMANIPULATOR | MQJ | Substantially Equivalent | |
| K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET | MQH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004871219 | 3003751666 | Research Instruments Ltd | Bickland Industrial Park, Falmouth Cornwall TR11 4TA GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1584-2016 | Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of Assisted Reproduction. The Rl Integra is a configuration comprising two TDU500 micromanipulators, two air syringes and temperature control system within a single housing. | The units have been fitted with a potentially faulty power supply cable. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain