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510(k) K792222

SHILEY LOW PRESSURE THIN-CUFFED TRACH. by Shiley, Inc. — Product Code EQN

K792222 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "SHILEY LOW PRESSURE THIN-CUFFED TRACH.". The FDA issued a decision of Substantially Equivalent on December 18, 1979. The device falls under product code EQN (Laryngoscope, Nasopharyngoscope), a Class II device regulated under 21 CFR 874.4760. Shiley, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1979
Date Received
November 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Nasopharyngoscope
Device Class
Class II
Regulation Number
874.4760
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Shiley, Inc.

  • K920594 — SHILEY PERFUSION TUBING SETS (March 18, 1993)
  • K910991 — SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (November 27, 1991)
  • K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 (August 9, 1991)
  • K910923 — BCD ADVANCED (April 9, 1991)
  • K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (January 14, 1991)
  • K903435 — SHILEY SPECIALIZED TRACHEOSTOMY TUBE (October 2, 1990)
  • K901624 — SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (July 3, 1990)
  • K901250 — PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)

Other clearances for product code EQN

  • K252624 — KARL STORZ Laryngoscopes and Accessories (May 15, 2026)
  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K834172 — OP-CON SURG. INSTRUMENT #7 (March 6, 1984)
  • K831255 — LARYNGOSCOPE ATTACHMENT PH2000 (September 12, 1983)
  • K830888 — COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (April 27, 1983)
  • K822525 — LARYNGOSCOPES RIGID (September 9, 1982)
  • K821707 — NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT (June 25, 1982)
  • K821709 — NAGASHIMA LIGHT SOURCE UNIT SL-5 (June 25, 1982)
  • K821706 — NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL (June 25, 1982)

FDA data resources