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510(k) K771732

THORNTON ANTERIOR CHAMBER IRRIGATOR by Concept, Inc. — Product Code GBQ

K771732 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "THORNTON ANTERIOR CHAMBER IRRIGATOR". The FDA issued a decision of Substantially Equivalent on September 28, 1977. The device falls under product code GBQ (Catheter, Continuous Irrigation), a Class I device regulated under 21 CFR 878.4200. Concept, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1977
Date Received
September 15, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Concept, Inc.

  • K912640 — CONCEPT ENDOSTEAL FIXATION DEVICE (May 1, 1992)
  • K912957 — CONCEPT MICROMILL (October 4, 1991)
  • K896648 — CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (June 5, 1990)
  • K894929 — STAPLE FIXATION SYSTEM (August 30, 1989)
  • K892376 — INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) (August 1, 1989)
  • K891109 — PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE (May 8, 1989)
  • K881954 — CONCEPT POWER SYSTEM (November 9, 1988)
  • K884255 — CONCEPT CCT-5200, THERMAL THERAPY SYSTEM (November 8, 1988)
  • K882121 — C-FLO SUCTION TUBE (June 20, 1988)
  • K880414 — TENDON HARVESTER (March 25, 1988)

Other clearances for product code GBQ

  • K941356 — MICROFLOW IRRIGATION SYSTEM (May 19, 1994)
  • K921464 — CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT (May 5, 1992)
  • K882647 — GESCO CATHETERIZATION TRAY (September 9, 1988)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K872787 — MODIFIED CURLCATH (August 4, 1987)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)

FDA data resources