510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933508Substantially Equivalent

Reflex Sdd Surgical Stapler

Richard-Allan Medical, Richland MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933508 is the FDA 510(k) clearance record for REFLEX SDD SURGICAL STAPLER, a class I device, cleared for Richard-Allan Medical on under FDA product code GEF (Applier, Staple, Surgical,). FDA records list 8 510(k) clearances for Richard-Allan Medical, from to . As of , FDA records show no recalls naming K933508.

Clearance record

Decision date
Received
(126 days to decision)
Product code
GEF Applier, Staple, Surgical,
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Richard-Allan Medical 8850m89, Box 351, Richland MI
510(k) summary
Summary
Third party review
No

Clearances, product code GEF

Trailing 12 months

FDA records hold no clearances under product code GEF in the trailing twelve months.

FDA records show no clearances under product code GEF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GEF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260