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510(k) K831078

STRAITH ORAL AIRWAY by Surgical Technology Laboratories, Inc. — Product Code CAE

K831078 is an FDA 510(k) premarket notification submitted by Surgical Technology Laboratories, Inc. for the device "STRAITH ORAL AIRWAY". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. Surgical Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1983
Date Received
April 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Oropharyngeal, Anesthesiology
Device Class
Class I
Regulation Number
868.5110
Review Panel
AN
Submission Type

Other clearances by Surgical Technology Laboratories, Inc.

  • K170582 — Saf-T-Vac Smoke and Fluid Evacuator (April 14, 2017)
  • K021889 — SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.) (October 16, 2002)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K983754 — STANDARD CHIN (November 20, 1998)
  • K964443 — SURGIFORM ANATOMICAL MALAR (December 20, 1996)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)
  • K801074 — STRAITH NASAL IMPLANT (June 17, 1980)
  • K801072 — STRAITH NASAL SPLINT (June 17, 1980)
  • K801075 — STRAITH CHISEL FORCEPS (May 20, 1980)

Other clearances for product code CAE

  • K130304 — LMA FAMILY OF AIRWAYS (May 30, 2014)
  • K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 30 (May 4, 2004)
  • K033186 — KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (April 14, 2004)
  • K021634 — KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (January 9, 2003)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K960240 — RUSCH OPTOSAFE (April 19, 1996)
  • K950613 — KEISEI (February 14, 1996)
  • K953400 — GUEDEL AIRWAY (October 24, 1995)
  • K933760 — STB GUEDEL AIRWAY (March 23, 1994)
  • K936134 — BERMAN AIRWAY (January 28, 1994)

FDA data resources