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510(k) K813000

DISPOSABLE ARTHROSCOPY CANNULA SET by Clinical Technology Corp. — Product Code LXH

K813000 is an FDA 510(k) premarket notification submitted by Clinical Technology Corp. for the device "DISPOSABLE ARTHROSCOPY CANNULA SET". The FDA issued a decision of Substantially Equivalent on January 22, 1982. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Clinical Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1982
Date Received
October 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Clinical Technology Corp.

  • K925080 — TEK-LUBE (January 31, 1994)
  • K872867 — BIOSIGN (July 6, 1988)
  • K880166 — BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 (February 18, 1988)
  • K872705 — BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) (September 1, 1987)
  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)
  • K854231 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES (May 2, 1986)
  • K853507 — STERI-GRIP (September 5, 1985)
  • K852986 — GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN (August 19, 1985)
  • K844565 — BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) (February 21, 1985)
  • K841272 — SICKLE-STAT HEMOGLOBIN S SCREEN KIT (April 13, 1984)

Other clearances for product code LXH

  • K192873 — SX-One MicroKnife (December 20, 2019)
  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944188 — SPINAL MARKER (April 13, 1995)
  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)

FDA data resources