FDA 510(k) Applications for Medical Device Product Code "BSR"
(Stylet, Tracheal Tube)

FDA 510(k) Number Applicant Device Name Decision Date
K932081 AARON MEDICAL, INC. LIGHTED INTUBATION SYLET 07/27/1993
K844557 ACKRAD LABORATORIES ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE 12/17/1984
K865108 ACKRAD LABORATORIES N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE 02/10/1987
K772046 AMERICAN HOSPITAL SUPPLY CORP. INTUBATION PROCEDURE KIT 11/23/1977
K912690 AUGUSTINE MEDICAL, INC. AUGUSTINE GUIDE(TM) KIT 09/04/1991
K910659 AUGUSTINE MEDICAL, INC. AUGUSTINE STYLET 05/17/1991
K920468 AUGUSTINE MEDICAL, INC. AUGUSTINE STYLET 04/23/1992
K905052 BIVONA MEDICAL TECHNOLOGIES BIVONA ENDOTRACHEAL TUBE STYLET 04/02/1991
K944729 COAST MEDICAL, INC. STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE 12/21/1994
K843490 CONCEPT, INC. TUBE-STAT 10/04/1984
K921128 EASTMED ENTERPRISES INC. ENDOTRACHEAL TUBE STYLET 06/02/1992
K933598 FIBEROPTIC MEDICAL PRODUCTS, INC. ENDOSTAR(TM) STYLET 01/25/1994
K922842 LAERDAL CALIFORNIA, INC. STYLET AND TRACHEAL LIGHTWAND (STL) 12/18/1992
K954771 LAERDAL MEDICAL CORP. TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) 05/09/1996
K962361 LAERDAL MEDICAL CORP. TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND 09/05/1996
K905133 MEDICAL DEVICES, INC. STYLET TRACHAEL TUBE 04/22/1991
K770374 MEDICAL PRODUCTS DIV. P.O.L.A. PLASTI STYLETTE, SLICK, CAT. NO. 2000B 03/30/1977
K943104 MOLLOY CORP. MOLLOY INTUBATING STYLETTE 04/18/1996
K904999 OPTICON MEDICAL, INC. WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE 01/26/1993
K914965 PIVIC PROMEDCO DISPOSABLE STYLETTE WITH END CAP 05/27/1992
K950713 POLAMEDCO, INC. AIRGUIDE STYLETTE 05/17/1995
K950380 POLAMEDCO, INC. FLEXTITIP STYLETTE 02/10/1995
K955238 RUSCH INTL. RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE 02/06/1996
K952100 RUSCH, INC. RUSCH ENDOTRACHEAL TUBE STYLET 08/08/1995
K940799 SCIENTIFIC SALES INTL., INC. FLEXGUIDE 08/18/1994
K953677 SCIENTIFIC SALES INTL., INC. LIGHTED FLEXGUIDE (MODIFICATION) 08/25/1995
K802416 SCIENTIFIC SALES INTL., INC. SALEM/RESCE INTUBATION GUIDE 10/23/1980
K832773 SHERIDAN CATHETER CORP. SHERI-I-SLIP INTUBATING STYLET 09/12/1983
K902180 SIMS SURGICAL, INC. TRACHEAL TUBE STYLET 07/19/1990
K935797 STEBAR INSTRUMENT CORP. SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE 01/12/1994
K952266 STEBAR INSTRUMENT CORP. SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE 06/12/1995


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