Panels › General, Plastic Surgery › Product code FYD · Class 2
Apparatus, Exhaust, Surgical
Regulation 878.5070
0510(k)s in 12 months (75 all time)
3recalls in 12 months (23 all time)
21recalls that name a 510(k)
Top companies in FYD
| Company | 510(k)s | Recalls |
|---|---|---|
| Buffalo Filter Co., Inc. | 21 | 0 |
| Microtek Medical Inc | 0 | 10 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 8 |
| I.C Medical, Inc. | 5 | 0 |
| SurgiSmoke Solutions | 0 | 3 |
| Conmed Corporation | 2 | 0 |
| Megadyne Medical Products, Inc. | 2 | 0 |
| Quinn Healthcare Products | 2 | 0 |
| Stackhouse Assoc. | 2 | 0 |
| Acuderm, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2026 | SurgiSmoke Solutions Flamingo Funnel Large, Model Number SQ20012-03 Open, Classified |
FYD | K894038 |
| Apr 22, 2026 | SurgiSmoke Solutions Flamingo Funnel Medium, Model Number SQ20012-02 Open, Classified |
FYD | K894038 |
| Apr 22, 2026 | SurgiSmoke Solutions Flamingo Funnel Small, Model Number SQ20012-01 Open, Classified |
FYD | K894038 |
| Sep 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560. Open, Classified |
FYD | K983298 |
| Sep 1, 2015 | Stryker Instruments Div. of Stryker Corporation Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished
Product Usage:
The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Terminated |
FYD | K132671 |
| Mar 27, 2015 | Microtek Medical Inc INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, or pow Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX
Intended use: The smoke evacuator and accessories are intended to evacuat Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke creat Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser su Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO
Intended use: The smoke evacuator and accessories are intended to evacuate the smoke created by electrosurgery, laser surgery, Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX
Intended use: The smoke evacuator and accessories are intended to Terminated |
FYD | K001082 K910515 |
| Mar 27, 2015 | Microtek Medical Inc LAPAROSCOPIC TUBING SET, 3/16" X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO
Intended use: The smoke evacuator and accessories are intended to evacuate the s Terminated |
FYD | K001082 K910515 |
| Apr 24, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker PenAdapt"; Rx Only, Sterile.
This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgic Terminated |
FYD | None listed |
| Aug 15, 2012 | Stryker Instruments Div. of Stryker Corporation Neptune Rover Waste Management System, Neptune 2 Ultra
Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste. Terminated |
FYD | K012991 |
| Aug 15, 2012 | Stryker Instruments Div. of Stryker Corporation Stryker Neptune Bronze Rover, Part 0700-007-000
Neptune Bronze Rover Waste Management System Instructions For Use.
Intended for use in the surgical environment or physician's office to collect and di Terminated |
FYD | K012991 |
| Aug 15, 2012 | Stryker Instruments Div. of Stryker Corporation Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International)
Instructions For Use 0700-001-700, 0700-002-707
Intended for use in the surgical e Terminated |
FYD | K012991 |
| Aug 15, 2012 | Stryker Instruments Div. of Stryker Corporation Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover
IFU part 0700-001-700 Terminated |
FYD | K012991 |
| Jul 28, 2010 | Microtek Medical Inc MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microt Terminated |
FYD | K001082 |
| Nov 4, 2004 | Stryker Instruments Div. of Stryker Corporation Stryker brand Neptune waste management system, Neptune Rover, 15 amp plug; model 0700-003-000. Terminated |
FYD | None listed |
| Nov 4, 2004 | Stryker Instruments Div. of Stryker Corporation Stryker brand Neptune waste management system, Neptune Rover, 20 amp plug; model 0700-001-000. Terminated |
FYD | K012991 K990037 |
| Feb 1, 2003 | Stryker Instruments, Instruments Div. Stryker brand Neptune waste management system; model 711-27-1. Terminated |
FYD | K012991 K990037 |
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