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Sign in to claim this brandMicro-tech Usa
US
Last updated May 23, 2026
What Micro-tech Usa makes
Micro-tech USA manufactures single-use accessories and components for endoscopic procedures, including insufflation tubing sets, valve kits for endoscope channels, cleaning utensils for surgical instruments, and bite blocks. Their portfolio also covers reusable and single-use items like reusable Bovie cords, irrigation tubing, and endoscopy preparation kits, as well as collection containers for surgical suction systems. These products are designed to support preparation, cleaning, and operation during endoscopic and surgical procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Micro-tech USA manufacture?
Micro-tech USA specializes in single-use and reusable accessories for endoscopic and surgical procedures. Their portfolio includes items like endoscope channel support kits, insufflation tubing sets, valve kits for endoscope channels, cleaning utensils for surgical instruments, bite blocks, and reusable Bovie cords. These products are designed to assist in preparation, cleaning, and operation during procedures, ensuring compatibility with endoscopy and surgical workflows.
Where is Micro-tech USA based, and what regulatory jurisdiction does it operate under?
Micro-tech USA is based in the United States. Their devices are intended for use within the U.S. regulatory framework, meaning they comply with FDA requirements applicable to medical devices in that jurisdiction. This includes classification under FDA’s Class I and Class II categories, which determine the level of regulatory oversight based on risk.
Which regulatory registries or databases list Micro-tech USA’s devices?
Micro-tech USA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identifying medical devices, ensuring traceability and transparency in the regulatory and healthcare systems. This listing helps healthcare providers and regulators verify the identity of the devices.
How are Micro-tech USA’s devices classified by regulatory authorities?
Micro-tech USA’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification is determined by the device’s intended use and potential risk to patients.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 079873914
Catalogue (72)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 3-Piece Valve Kit | BW01-FUJ3-F7 | FDA UDI | Class II | Active |
| Active Cord Reusable Bovie | AEC-03-08 | FDA UDI | Class II | Active |
| 5-Piece Valve Kit | BW01-FUJ5-F56 | FDA UDI | Class II | Active |
| A/W Channel Cleaning Adapter + 4-Piece Valve Kit | AW01-OLY5 | FDA UDI | Class II | Active |
| ProTrap Luma | BBPA10001 | FDA UDI | Class II | Active |
| Endoscopy Kit - Upper | MDKT1A0002A | FDA UDI | Class I | Active |
| 5-Piece Valve Kit | BW01-FUJ5-F7 | FDA UDI | Class II | Active |
| Air/Water Bottle CO2 Tubing | AW02-OLYC02 | FDA UDI | Class II | Active |
| In-Sight | MDHL100000A | FDA UDI | Class II | Active |
| Endoscopy Kit - Basic+ | MDKT1A0005A | FDA UDI | Class I | Active |
| Irrigation Tubing Set | BW02-IRRTUBSL | FDA UDI | Class II | Active |
| 5-Piece Valve Kit | BW01-OLY5 | FDA UDI | Class II | Active |
| Endoscopy Kit - Basic w Aux Water | KT1A0008A | FDA UDI | Class II | Active |
| Irrigation Tubing Set | AW02-OLYTUB | FDA UDI | Class II | Active |
| ProTrap Luma | BBPA00001 | FDA UDI | Class II | Active |
| Jacket Biopsy Valve | MD-A-BV02 | FDA UDI | Class II | Active |
| Disposable Biopsy Valve | BW01-OLYB | FDA UDI | Class II | Active |
| Double Ended Valve Brush + Single Ended Channel Brush | MDBR1B0013A | FDA UDI | Class I | Active |
| Endoscopy Device Organizer | EDO-1000-5 | FDA UDI | Class I | Active |
| 3-Piece Valve Kit | AW01-PEN3 | FDA UDI | Class II | Active |
| Endoscope Cleaning Sponge | MDSB1B0001A | FDA UDI | Class I | Active |
| CO2 Source Tubing Filter Olympus | BW02-CO2TUBOLY | FDA UDI | Class II | Active |
| 3-Piece Valve Kit | BW01-OLY3 | FDA UDI | Class II | Active |
| Disposable Biopsy Valve | BW01-PENB | FDA UDI | Class II | Active |
| Endoscopy Kit - Compliance | MDKT1A0004A | FDA UDI | Class I | Active |
| Double Ended Channel Brush | MDBR1B0016A | FDA UDI | Class I | Active |
| Endoscopy Kit - Compliance | KT1A0004A | FDA UDI | Class I | Active |
| 4-Piece Valve Kit | AW01-PEN4 | FDA UDI | Class II | Active |
| Air/Water Bottle Tubing | AW02-OLY | FDA UDI | Class II | Active |
| Jacket Air/Water & Suction Valve Kit | MD-A-AW01 | FDA UDI | Class II | Active |
| Air/Water Channel Cleaning Adapter | BW01-FUJC-F56 | FDA UDI | Class I | Active |
| Rotatable Grasping Forcep | QR01-ART | FDA UDI | Class II | Active |
| 3-Piece Valve Kit | AW01-OLY3 | FDA UDI | Class II | Active |
| Auxiliary Water Connector | BW01-PENA | FDA UDI | Class II | Active |
| Scope Tip Protector | BW03-DTPS | FDA UDI | Class I | Active |
| 4-Piece Valve Kit | BW01-OLY4 | FDA UDI | Class II | Active |
| Endoscopy Kit - Compliance+ FUJ5 Kit | KT1A0010A | FDA UDI | Class II | Active |
| Irrigation Tubing Set | BW02-IRRTUB | FDA UDI | Class II | Active |
| Single Ended Channel Brush | MDBR1A0504A | FDA UDI | Class I | Active |
| Endoscopy Kit - Compliance+ | KT1A0006A | FDA UDI | Class I | Active |
| Breathe-EZ | MDBB1AY003A | FDA UDI | Class I | Active |
| Single End Channel Attached Valve Brush | MDBR1B0015A | FDA UDI | Class I | Active |
| Jacket Air/Water & Suction Valve Kit | MD-B-AW01 | FDA UDI | Class II | Active |
| Endoscopy Kit - Set Up | MDKT1A0003A | FDA UDI | Class I | Active |
| Auxiliary Water Connector | BW01-OLYA | FDA UDI | Class II | Active |
| Polyp Trap single chamber bulk | PT50-50-S | FDA UDI | Class II | Active |
| Air/Water Bottle Tubing | BW02-OLY | FDA UDI | Class II | Active |
| 4-Piece Valve Kit | AW01-OLY4 | FDA UDI | Class II | Active |
| Sterile Bacteriostatic Lubricating Gel | MDJL1A0001A | FDA UDI | Class I | Active |
| Bite Block Adult | MDBB1AY001A | FDA UDI | Class I | Active |
Related Companies
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Micro-Tech USA has one recall record initiated on 2020-10-05, which is listed with a terminated status. The recall pertains to the Elastic Traction Device, with the reason filed stating that the FDA determined the device requires 510(k) clearance and is not appropriately classified as a Class I device.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 5, 2020 | Z-0470-2021 | — | terminated | FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US. |