510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221206Substantially Equivalent

Compass Steerable Needle

Serpex Medical, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221206 is the FDA 510(k) clearance record for Compass Steerable Needle, a class II device, cleared for Serpex Medical, Inc. on under FDA product code KTI (Bronchoscope Accessory). FDA's definition for product code KTI reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 4 510(k) clearances for Serpex Medical, Inc., from to . As of , FDA records show no recalls naming K221206.

Clearance record

Decision date
Received
(121 days to decision)
Product code
KTI Bronchoscope Accessory
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Serpex Medical, Inc. 3350 Scott Blvd., Santa Clara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KTI

Trailing 12 months
4 clearances under product code KTI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KTI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260