510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K072684Substantially Equivalent

Mondeal Endoscopic Tissue Recession and Release System

Mondeal North America, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072684 is the FDA 510(k) clearance record for MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM, a class II device, cleared for Mondeal North America, Inc. on under FDA product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered). FDA's definition for product code OCZ reads: "To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope". FDA records list one 510(k) clearance for Mondeal North America, Inc. As of , FDA records show no recalls naming K072684.

Clearance record

Decision date
Received
(105 days to decision)
Product code
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mondeal North America, Inc. P.O. Box 500521, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCZ

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