Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K832010Substantially Equivalent

Broncho-Fiberscope

Karl Storz Endoscopy-America, Inc., Mchenry IL / Traditional, Substantially Equivalent

K832010 is the FDA 510(k) clearance record for BRONCHO-FIBERSCOPE, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)). FDA's definition for product code EOQ reads: "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the...". FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show one recall naming K832010.

Clearance record

Decision date
Received
(39 days to decision)
Product code
EOQ Bronchoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
KARL STORZ Endoscopy-America, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EOQ

Trailing 12 months
11 clearances under product code EOQ in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EOQ, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20262
May 20261
June 20261
July 20262
August 20260
September 20263
October 20260