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510(k) K933508

REFLEX SDD SURGICAL STAPLER by Richard-Allan Medical — Product Code GEF

K933508 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical for the device "REFLEX SDD SURGICAL STAPLER". The FDA issued a decision of Substantially Equivalent on November 23, 1993. The device falls under product code GEF (Applier, Staple, Surgical,), 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
November 23, 1993
Date Received
July 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Staple, Surgical,
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)
  • K933901 — REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) (November 19, 1993)
  • K924881 — REFLEX(R) ESP (July 23, 1993)
  • K924929 — REFLEX(R) ECA (July 21, 1993)
  • K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)
  • K905701 — RICHARD-ALLAN SHEET CLIP (February 19, 1991)

Other clearances for product code GEF

  • K915670 — MICROAIRE MODEL 2600 (March 18, 1992)
  • K854568 — V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP (December 2, 1985)
  • K823888 — 3M FRASCIA STAPLING SYSTEM (January 9, 1983)

FDA data resources