510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930302Substantially Equivalent

Birtcher Sure Clean Instrument System

Birtcher Medical Systems, Inc., Duluth GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930302 is the FDA 510(k) clearance record for BIRTCHER SURE CLEAN INSTRUMENT SYSTEM, a class II device, cleared for Birtcher Medical Systems, Inc. on under FDA product code GCI (Laryngoscope, Endoscope). FDA records list 13 510(k) clearances for Birtcher Medical Systems, Inc., from to . As of , FDA records show no recalls naming K930302.

Clearance record

Decision date
Received
(279 days to decision)
Product code
GCI Laryngoscope, Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Birtcher Medical Systems, Inc. 4775 River Green Pkwy., Duluth GA
510(k) summary
Statement
Third party review
No

Clearances, product code GCI

Trailing 12 months

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

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