Home / 510(k) Clearances / K904999

510(k) K904999

WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE by Opticon Medical, Inc. — Product Code BSR

K904999 is an FDA 510(k) premarket notification submitted by Opticon Medical, Inc. for the device "WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE". The FDA issued a decision of Substantially Equivalent on January 26, 1993. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Opticon Medical, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1993
Date Received
November 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Tracheal Tube
Device Class
Class I
Regulation Number
868.5790
Review Panel
AN
Submission Type

Other clearances by Opticon Medical, Inc.

  • K041983 — OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 (November 17, 2004)
  • K033830 — OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRA (January 9, 2004)
  • K023090 — OPTION-VF URINARY CATHETER, FV14218 (March 19, 2003)
  • K970716 — OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE (May 16, 1997)
  • K930194 — HEMOSTASIS VALVE AND TUBING SET (September 22, 1993)
  • K895955 — LOPER CELIAC PLEXUS BLOCK CATHETER KIT (February 22, 1990)
  • K895476 — OPTION EPIDURAL CATHETERS (January 19, 1990)

Other clearances for product code BSR

  • K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exc (August 11, 2017)
  • K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (September 5, 1996)
  • K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRA (May 9, 1996)
  • K943104 — MOLLOY INTUBATING STYLETTE (April 18, 1996)
  • K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (February 6, 1996)
  • K953677 — LIGHTED FLEXGUIDE (MODIFICATION) (August 25, 1995)
  • K952100 — RUSCH ENDOTRACHEAL TUBE STYLET (August 8, 1995)
  • K952266 — SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (June 12, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)

FDA data resources