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510(k) K961536

FLEXSCOPE by Matrix Medica, Inc. — Product Code GDB

K961536 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "FLEXSCOPE". The FDA issued a decision of Substantially Equivalent on September 18, 1996. The device falls under product code GDB (Endoscope, Fiber Optic), a Class II device regulated under 21 CFR 876.1500. Matrix Medica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1996
Date Received
April 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Fiber Optic
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Matrix Medica, Inc.

  • K923693 — KLORMAN (January 23, 1996)
  • K921982 — MATRX HOPE(R) 5 RESUSCITATOR (October 28, 1994)
  • K915353 — MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP (December 27, 1991)
  • K912661 — MATRX, PYRAMID TRIANGLE BANDAGE (August 21, 1991)
  • K900551 — MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. (May 9, 1990)
  • K895533 — LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER (January 26, 1990)
  • K895525 — MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER (January 26, 1990)
  • K893219 — MATRX DENTAL UNIT (August 7, 1989)
  • K883833 — NITRONOX(R), FIRST RESPONSE NITRONOX(TM) (February 17, 1989)
  • K884879 — CENTURION(TM) MIXER (February 9, 1989)

Other clearances for product code GDB

  • K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHT (August 20, 2003)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • K882061 — OLYMPUS GF-UM3/EU-M3 (November 15, 1988)
  • K855151 — FRITCH OPHTHALMIC ENDOSCOPE (February 19, 1986)
  • K843900 — FOCUSCOPE UNIVERSAL SYSTEM (December 6, 1984)
  • K810007 — PENTAX UPPER G.I. FIBERSCOPE, #FG-34 (January 15, 1981)

FDA data resources