510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951569Substantially Equivalent

Surgactivator

Deschutes Medical Products, Inc., Bend OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951569 is the FDA 510(k) clearance record for SURGACTIVATOR, a class II device, cleared for Deschutes Medical Products, Inc. on under FDA product code LJH (System, Irrigation, Urological). FDA records list 8 510(k) clearances for Deschutes Medical Products, Inc., from to . As of , FDA records show no recalls naming K951569.

Clearance record

Decision date
Received
(63 days to decision)
Product code
LJH System, Irrigation, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Deschutes Medical Products, Inc. P.O. Box 627, Bend OR
510(k) summary
Statement
Third party review
No

Clearances, product code LJH

Trailing 12 months
1 clearance under product code LJH in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJH, 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 20261
October 20260