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510(k) K892069

EXTENDED COVERS, STERILE by Amedic USA — Product Code FFF

K892069 is an FDA 510(k) premarket notification submitted by Amedic USA for the device "EXTENDED COVERS, STERILE". The FDA issued a decision of Substantially Equivalent on August 8, 1989. The device falls under product code FFF (Cover, Biopsy Forceps), a Class I device regulated under 21 CFR 876.1075. Amedic USA has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1989
Date Received
March 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Biopsy Forceps
Device Class
Class I
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Amedic USA

  • K897120 — EQUIP COVERS, STERILE (January 4, 1990)
  • K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE (September 5, 1989)
  • K892071 — GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE (August 8, 1989)
  • K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE (August 4, 1989)
  • K871467 — BIOPSY NEEDLE GUIDE KIT, STERILE (August 21, 1987)
  • K871565 — ULTRASOUND TRANSDUCER GEL, STERILE (July 15, 1987)
  • K871609 — ULTRASOUND TRANSDUCER SHEATHS, STERILE (July 15, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K864219 — TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE (March 27, 1987)

FDA data resources