510(k) K910515 ยท FYA Gown, Surgical
FREEDOM MARK III SURGICAL HELMET SYSTEM
| Applicant | Stackhouse Assoc., Riverside CA, US |
| Decision | Substantially Equivalent, May 6, 1991 |
| Received | Feb 5, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2015 | Microtek Medical Inc FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical pe Terminated |
FYA | None listed |
| Mar 27, 2015 | Microtek Medical Inc FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment Terminated |
FYA | None listed |
| Mar 27, 2015 | Microtek Medical Inc FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating Terminated |
FYA | None listed |
| Mar 27, 2015 | Microtek Medical Inc FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating Terminated |
FYA | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Oct 4, 2005 | VIASYS Med Systems Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to co Terminated |
FXY | None listed |
| Oct 4, 2005 | VIASYS Med Systems Stackhouse Lens/Hood, Mark III Universal; a sterile disposable protective head garment for use with the Stackhouse Mark III Helmet, providing a clear plastic bubble lens and protective head hood to co Terminated |
FXY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.