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510(k) K955238

RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE by Rusch Intl. — Product Code BSR

K955238 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE". The FDA issued a decision of Substantially Equivalent on February 6, 1996. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Rusch Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1996
Date Received
November 14, 1995
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 Rusch Intl.

  • K033023 — INTERMITTENT URETHRAL CATHETERS (December 23, 2003)
  • K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM (June 30, 2003)
  • K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (June 17, 2003)
  • K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS (March 28, 2003)
  • K023964 — RUSCH MICROLARYNGEAL TUBE (December 23, 2002)
  • K021540 — RUSCH EDGAR TUBE (August 1, 2002)
  • K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (July 23, 2002)
  • K020714 — RUSCH FLONEIL; FLOCATH INTROGEL (July 1, 2002)
  • K010797 — RUSCH MILLER-ABBOTT TUBE (February 26, 2002)
  • K010798 — RUSCH CANTOR TUBE (February 26, 2002)

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)
  • 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)
  • K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (December 21, 1994)

FDA data resources