ClearanceBrief
510(k) K910515 ยท FYA Gown, Surgical

FREEDOM MARK III SURGICAL HELMET SYSTEM

ApplicantStackhouse Assoc., Riverside CA, US
DecisionSubstantially Equivalent, May 6, 1991
ReceivedFeb 5, 1991
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K910515

DateFirm and productCodeLinked 510(k)
Mar 27, 2015Microtek 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
FYANone listed
Mar 27, 2015Microtek 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
FYANone listed
Mar 27, 2015Microtek 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
FYANone listed
Mar 27, 2015Microtek 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
FYANone listed
Mar 27, 2015Microtek 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
FYDNone listed
Mar 27, 2015Microtek 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
FYDNone listed
Mar 27, 2015Microtek 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
FYDNone listed
Mar 27, 2015Microtek 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
FYDNone listed
Mar 27, 2015Microtek 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
FYDNone listed
Mar 27, 2015Microtek 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
FYDNone listed
Mar 27, 2015Microtek 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
FYDNone listed
Mar 27, 2015Microtek 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
FYDNone listed
Mar 27, 2015Microtek 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
FYDNone listed
Oct 4, 2005VIASYS 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
FXYNone listed
Oct 4, 2005VIASYS 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
FXYNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.