510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070915Substantially Equivalent

Sapimed Disposable Sigmoidoscope

Sapimed S.p.A., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070915 is the FDA 510(k) clearance record for SAPIMED DISPOSABLE SIGMOIDOSCOPE, a class II device, cleared for Sapimed S.P.A. on under FDA product code KDM (Sigmoidoscope, Rigid, Non-Electrical). FDA records list 3 510(k) clearances for Sapimed S.P.A., from to . As of , FDA records show one recall naming K070915.

Clearance record

Decision date
Received
(95 days to decision)
Product code
KDM Sigmoidoscope, Rigid, Non-Electrical
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sapimed S.P.A. 1676 Village Green Suite A, Crofton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDM

Trailing 12 months

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

FDA records show no clearances under product code KDM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KDM, 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