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510(k) K833297

BRONCHOSCOPY TUBE W/ULTRA LOCUFF by Surgitek — Product Code BTS

K833297 is an FDA 510(k) premarket notification submitted by Surgitek for the device "BRONCHOSCOPY TUBE W/ULTRA LOCUFF". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code BTS (Tube, Bronchial (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5720. Surgitek has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
September 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Bronchial (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5720
Review Panel
AN
Submission Type

Other clearances by Surgitek

  • K946296 — QUADRA-COIL URETERAL STENT (March 6, 1995)
  • K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM (February 7, 1995)
  • K943491 — RIGHT ANGLE UROLOGIC LASER FIBER (August 5, 1994)
  • K941952 — SURGITEK INFUSER (May 24, 1994)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K933260 — HELICAL STONE/FLATWIRE STONE BASKETS (January 11, 1994)
  • K930733 — URETERAL STENT (July 23, 1993)
  • K930483 — URETERAL CATHETER (July 16, 1993)
  • K926344 — HYDROPHILIC COATED GUIDEWIRE (March 5, 1993)
  • K920451 — ENDOTEK ULTRA SYSTEM (September 17, 1992)

Other clearances for product code BTS

  • K953963 — RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIA (November 27, 1995)
  • K951091 — RUSCH ENDOBRONCHIAL TUBE SETS (June 8, 1995)
  • K902116 — MODIFIED ENDOBRONCHIAL TUBE (August 3, 1990)
  • K834565 — ENDOBRONCHIAL TWIN LUMEN TUBE (January 17, 1984)
  • K771219 — BRONCHO-CATH (August 4, 1977)

FDA data resources