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510(k) K924929

REFLEX(R) ECA by Richard-Allan Medical — Product Code HBT

K924929 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical for the device "REFLEX(R) ECA". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code HBT (Applier, Hemostatic Clip), a Class I device regulated under 21 CFR 878.4800. Richard-Allan Medical has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1993
Date Received
September 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Hemostatic Clip
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Richard-Allan Medical

  • K942207 — REFLEX INS INSUFFLATION NEEDLE (May 27, 1994)
  • K935105 — REFLEX ESP WITH FINGER SWITCHES (February 22, 1994)
  • K933508 — REFLEX SDD SURGICAL STAPLER (November 23, 1993)
  • K933901 — REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) (November 19, 1993)
  • K924881 — REFLEX(R) ESP (July 23, 1993)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)
  • K905701 — RICHARD-ALLAN SHEET CLIP (February 19, 1991)

Other clearances for product code HBT

  • K896262 — TITANIUM LIGATING CLIPS (January 2, 1990)
  • K862696 — TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP (July 30, 1986)
  • K800318 — DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI (March 10, 1980)

FDA data resources