510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K071764Substantially Equivalent

Realize Gastric Calibration Tube, Models Gct180, Gct360

Obtech Medical SARL, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071764 is the FDA 510(k) clearance record for REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360, a class II device, cleared for Obtech Medical Sarl on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list one 510(k) clearance for Obtech Medical Sarl. As of , FDA records show no recalls naming K071764.

Clearance record

Decision date
Received
(117 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Obtech Medical Sarl 4545 Creek Rd., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNT

Trailing 12 months
3 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20261
October 20260