510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K150280Substantially Equivalent

PulmoVia Working Channel

Sanovas, Inc., San Rafael CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150280 is the FDA 510(k) clearance record for PulmoVia Working Channel, a class II device, cleared for Sanovas, 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 one 510(k) clearance for Sanovas, Inc. As of , FDA records show no recalls naming K150280.

Clearance record

Decision date
Received
(126 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
Sanovas, Inc. 2597 Kerner Blvd., San Rafael CA
510(k) summary
Summary PDF
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