Boehringer Laboratories Suction Pump System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061788 FDA 510(k)
- FDA Product Code
- OMP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Boehringer Laboratories Suction Pump System is a Negative Pressure Wound Therapy Powered Suction Pump, classified as a Class II medical device under FDA regulation number 878.4780. It is designed for the application of low flow suction to remove fluids, including irrigation fluids, body fluids, and infectious materials.
The device is supplied as a powered suction pump system and is intended for use in general and plastic surgery settings. It has received FDA 510(k) clearance under K061788 and is substantially equivalent to a legally marketed device. The system is manufactured by Boehringer Laboratories, LLC in Norristown, PA, and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.
Frequently asked questions
What is the Boehringer Laboratories Suction Pump System used for?
It is designed for the application of low flow suction to remove fluids, including irrigation fluids, body fluids, and infectious materials, in general and plastic surgery settings.
How is the Boehringer Laboratories Suction Pump System supplied?
The device is supplied as a powered suction pump system, as stated in the device description, with no indication of sterility, single-use, or reusable status in the provided data.
What regulatory pathway was used for the Boehringer Laboratories Suction Pump System?
It received FDA 510(k) clearance under K061788 and is substantially equivalent to a legally marketed device, as indicated by the decision code SESE and clearance type Traditional.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Boehringer Labs | Innovative Medical Device for Surgical Care, BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (K060277) — FDA 510 (k ..., Suction Regulators by Boehringer Labs - Precision Vacuum Control, Suction Regulators - Trusted Medical Vacuum Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061788 | Class II | Active |
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Manufacturer
- Manufacturer
- Boehringer Laboratories, Llc
- FDA Applicant
- Boehringer Laboratories
Sources (1)
- FDA 510(k) K061788 24 fields · synced Sep 26, 2026