510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870978Substantially Equivalent

T-Tube Inserter

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

K870978 is the FDA 510(k) clearance record for T-TUBE INSERTER, a class I device, cleared for Sur-Med Instruments, Inc. on under FDA product code JYM (Inserter, Myringotomy Tube). FDA records list 3 510(k) clearances for Sur-Med Instruments, Inc., from to . As of , FDA records show no recalls naming K870978.

Clearance record

Decision date
Received
(9 days to decision)
Product code
JYM Inserter, Myringotomy Tube
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Sur-Med Instruments, Inc. 9422-24 Gravois Rd., St. Louis MO
Third party review
No

Clearances, product code JYM

Trailing 12 months

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

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