510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131803Substantially Equivalent

Guardian Urethral Sheath

Solace Therapeutics, Farmingham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131803 is the FDA 510(k) clearance record for GUARDIAN URETHRAL SHEATH, a class II device, cleared for Solace Therapeutics on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 4 510(k) clearances for Solace Therapeutics, from to . As of , FDA records show no recalls naming K131803.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Solace Therapeutics 135 Newbury St., Farmingham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNY

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