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510(k) K895681

CONTRAST BACKGROUND MATERIAL by Applied Medical Technologies — Product Code GAB

K895681 is an FDA 510(k) premarket notification submitted by Applied Medical Technologies for the device "CONTRAST BACKGROUND MATERIAL". The FDA issued a decision of Substantially Equivalent on October 24, 1989. The device falls under product code GAB (Needle, Suturing, Disposable), a Class I device regulated under 21 CFR 878.4800. Applied Medical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1989
Date Received
September 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Suturing, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Applied Medical Technologies

  • K971434 — A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE (August 17, 1998)
  • K972478 — PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES (February 9, 1998)
  • K973893 — AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON M (December 19, 1997)
  • K971757 — LOW PROFILE FEEDING SET ACCESSORY (November 7, 1997)
  • K971758 — CAUTERIZATION SMOKE EVACUATOR (July 21, 1997)
  • K961345 — DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE (September 17, 1996)
  • K960232 — ENDOSCOPIC ACCESS DEVICE (March 21, 1996)
  • K945618 — GASTROINTESTINAL TUBES & ACCESSORIES (October 12, 1995)
  • K946140 — PRG BUTTON (August 28, 1995)
  • K923488 — GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY (July 20, 1995)

Other clearances for product code GAB

  • K012199 — DIGICAP (December 19, 2001)
  • K980988 — AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) (May 11, 1998)
  • K932591 — ENDO-JUDGE (December 22, 1993)
  • K863595 — COATED SUTURE NEEDLE (October 24, 1986)
  • K831648 — ANCHOR BRAND SURGICAL NEEDLES (August 16, 1983)
  • K812444 — RADIATION STERILIZATION FOR NEEDLE CNTR (December 14, 1981)
  • K801976 — SCANLAN STERNUM NEEDLE-SUTURE (September 26, 1980)

FDA data resources