510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840800Substantially Equivalent

Polyp-Saver Sleve

Jayco Pharmaceuticals, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840800 is the FDA 510(k) clearance record for POLYP-SAVER SLEVE, a class II device, cleared for Jayco Pharmaceuticals 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 9 510(k) clearances for Jayco Pharmaceuticals, from to . As of , FDA records show no recalls naming K840800.

Clearance record

Decision date
Received
(29 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
Jayco Pharmaceuticals 803 N. Front St. Suite 3, Mchenry IL
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