510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092829Substantially Equivalent

Insertease

Christcot Medical Company, Sudbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092829 is the FDA 510(k) clearance record for INSERTEASE, a class I device, cleared for Christcot Medical Company on under FDA product code OOW (Applicator For Rectal Suppository). FDA's definition for product code OOW reads: "Intended for use in the insertion of suppositories into the rectum". FDA records list one 510(k) clearance for Christcot Medical Company. As of , FDA records show no recalls naming K092829.

Clearance record

Decision date
Received
(78 days to decision)
Product code
OOW Applicator For Rectal Suppository
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Christcot Medical Company P.O. Box 104, Sudbury MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOW

Trailing 12 months

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

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