Data / Medical devices / United States / SurgiSmoke Solutions
SurgiSmoke Solutions: FDA-registered device maker in Saint Paul, MN, United States, 1 510(k) clearance
SurgiSmoke Solutions is registered with the FDA (registration 3008493151) in Saint Paul, MN, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 28, 1989. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008493151
- Address
- 2300 Myrtle Ave Ste 200, Saint Paul, MN, United States, 55114
- Owner or operator
- Nascent Surgical, LLC (10033248)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 26, 2010
- Registered through
- 2026
- Brand names listed
- Flamingo Funnel Small, Flamingo Funnel Medium, and Flamingo Funnel Large, MiniSQUAIR, MicroSQUAIR, NanoSQUAIR, SurgiSmoke Solution's Nonsterile Extension Tubing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Air-Handling Apparatus Accessory | QGI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Apparatus, Exhaust, Surgical | FYD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 28, 1989 | K894038 | PLUME-AWAY SMOKE EVACUATION SYSTEM | FYD | Substantially Equivalent | Laser Technologies Group, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 16, 2026 | 98574 | Class II | Ongoing | Flamingo Funnel Small, Model Number SQ20012-01 | Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. | accessdata.fda.gov |
Compare with other makers
Updated April 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.