510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K830247Substantially Equivalent

Split Colon Stiffening Tube

Keymed, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830247 is the FDA 510(k) clearance record for SPLIT COLON STIFFENING TUBE, a class II device, cleared for Keymed, Inc. on under FDA product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). FDA's definition for product code FED reads: "To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation". FDA records list 29 510(k) clearances for Keymed, Inc., from to . As of , FDA records show no recalls naming K830247.

Clearance record

Decision date
Received
(49 days to decision)
Product code
FED Endoscopic Access Overtube, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Keymed, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FED

Trailing 12 months
5 clearances under product code FED in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20263
October 20260