510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030919Substantially Equivalent

Siss, Inc. (D.b.a.medisiss) Reprocessd Electrosurgical Instruments and Accessories

Medisiss, Sisters OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030919 is the FDA 510(k) clearance record for SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES, a class II device, cleared for Medisiss on under FDA product code NLR (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed). FDA's definition for product code NLR reads: "This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be...". FDA records list 6 510(k) clearances for Medisiss, from to . As of , FDA records show no recalls naming K030919.

Clearance record

Decision date
Received
(101 days to decision)
Product code
NLR Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medisiss 723 Curtis Ct., Sisters OR
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code NLR

Trailing 12 months

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

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