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510(k) K770194

NASO-LACRIMAL DUCT INSERT by Concept, Inc. — Product Code HNL

K770194 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "NASO-LACRIMAL DUCT INSERT". The FDA issued a decision of Substantially Equivalent on February 14, 1977. The device falls under product code HNL (Probe, Lachrymal), a Class I device regulated under 21 CFR 886.4350. Concept, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1977
Date Received
January 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Lachrymal
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
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 HNL

  • K843491 — CONCEPT FIBER OPTIC CANALICULUS INTUBA (October 5, 1984)
  • K840861 — TSE-ANDERSON MODIFIED LACRIMAL GROOV (May 9, 1984)
  • K833671 — STERILE OIL AND GUIDEWIRE (January 10, 1984)
  • K831901 — LACIMAL INTUBATION SETS (July 12, 1983)
  • K813187 — PILLING LACRIMAL INTUBATION SYSTEM (January 28, 1982)
  • K812255 — ETHICON LACRIMAL STENT (August 20, 1981)
  • K802845 — CONCEPT CANALICULUS INTUBATION SET (December 17, 1980)
  • K801232 — JACKSON LACRIMAL INTUBATION SET (June 17, 1980)
  • K800089 — CRAWFORD LACRIMAL INTUBATION SET (March 3, 1980)

FDA data resources