510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870897Substantially Equivalent

Kodner Anal Perioneal Retractor

Sur-Med Instruments, Inc., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870897 is the FDA 510(k) clearance record for KODNER ANAL PERIONEAL RETRACTOR, a class I device, cleared for Sur-Med Instruments, Inc. on under FDA product code FFO (Retractor, Self-Retaining). FDA records list 3 510(k) clearances for Sur-Med Instruments, Inc., from to . As of , FDA records show no recalls naming K870897.

Clearance record

Decision date
Received
(91 days to decision)
Product code
FFO Retractor, Self-Retaining
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Sur-Med Instruments, Inc. 9422-24 Gravois Rd., St. Louis MO
Third party review
No

Clearances, product code FFO

Trailing 12 months

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

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