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510(k) K902056

LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER by Hollister, Inc. — Product Code JDY

K902056 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER". The FDA issued a decision of Substantially Equivalent on October 30, 1990. The device falls under product code JDY (Evacuator, Vapor, Cement Monomer), a Class I device regulated under 21 CFR 888.4220. Hollister, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1990
Date Received
May 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Vapor, Cement Monomer
Device Class
Class I
Regulation Number
888.4220
Review Panel
OR
Submission Type

Other clearances by Hollister, Inc.

  • K123804 — INSTAFLO BOWEL CATHETER SYSTEM KIT (April 17, 2013)
  • K100273 — INSTAFLO BOWEL CATHETER SYSTEM KIT (April 22, 2010)
  • K090960 — VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 7208 (August 20, 2009)
  • K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 (February 4, 2009)
  • K050483 — EVADRI BLADDER CONTROL SYSTEMS (April 12, 2005)
  • K040779 — RESTORE WOUND CLEANSER (May 17, 2004)
  • K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM (March 19, 2002)
  • K013653 — INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE (March 5, 2002)
  • K013483 — INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (January 14, 2002)
  • K013345 — INCARE INTERMITTENT CATHETER (January 7, 2002)

Other clearances for product code JDY

  • K902167 — CONTAIN(TM) LASER PLUME FILTER (January 4, 1991)
  • K862509 — CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 (July 23, 1986)
  • K810542 — CEMENT FUME EVACUATOR TANK & FILTER (March 13, 1981)
  • K790877 — BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO (May 23, 1979)
  • K780202 — MONOMER EVACUATION SYSTEM (February 21, 1978)
  • K770690 — MASK, VAPOR, MONOMER (July 21, 1977)
  • K760906 — MONOMER VAPOR CONTAINMENT SYSTEM (November 11, 1976)

FDA data resources