510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033593Substantially Equivalent

Reprocessed Single Use Devices Biopsy Forceps

Clearmedical, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033593 is the FDA 510(k) clearance record for REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS, a class II device, cleared for Clearmedical, Inc. on under FDA product code NLU (Forceps, Biopsy, Electric, Reprocessed). FDA's definition for product code NLU reads: "The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3)...". FDA records list 14 510(k) clearances for Clearmedical, Inc., from to . As of , FDA records show no recalls naming K033593.

Clearance record

Decision date
Received
(7 days to decision)
Product code
NLU Forceps, Biopsy, Electric, Reprocessed
Regulation
21 CFR 876.4300
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Clearmedical, Inc. 1776 136th Pl. NE, Bellevue WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLU

Trailing 12 months

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

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