510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911461Substantially Equivalent

Surgitron

Ellman Intl. Mfg., Inc., Hewlett NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911461 is the FDA 510(k) clearance record for SURGITRON, a class II device, cleared for Ellman Intl. Mfg., Inc. on under FDA product code GCI (Laryngoscope, Endoscope). FDA records list 2 510(k) clearances for Ellman Intl. Mfg., Inc., from to . As of , FDA records show no recalls naming K911461.

Clearance record

Decision date
Received
(22 days to decision)
Product code
GCI Laryngoscope, Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ellman Intl. Mfg., Inc. 1135 Railroad Ave., Hewlett NY
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