510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910788Substantially Equivalent

Cmi Tender Touch Ve #303Tt and 404Tt

Challenge Mfg., Inc., Bend OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910788 is the FDA 510(k) clearance record for CMI TENDER TOUCH VE #303TT AND 404TT, a class II device, cleared for Challenge Mfg., Inc. on under FDA product code HIS (Condom). FDA records list 4 510(k) clearances for Challenge Mfg., Inc., from to . As of , FDA records show no recalls naming K910788.

Clearance record

Decision date
Received
(73 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Challenge Mfg., Inc. P.O. Box 5877, Bend OR
Third party review
No

Clearances, product code HIS

Trailing 12 months
3 clearances under product code HIS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260