Chrysalis Intelligence · Sponsors · Tusker Medical, Inc.

Tusker Medical, Inc.

Austin, TX, US · 1 510(k) clearances · 11 PMAs

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Total clearances
1
2026-04-23 → 2026-04-23
Last 12 months
1
Product codes
1
Most recent
2026-04-23
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ETD Tube, Tympanostomy Class II Ear, Nose, Throat 1 2026-04-23
Class III

PMA approvals (11)

Total PMA records
11
Originals + supplements
Distinct product codes
1
First decision
2020-05-06
Most recent
2026-07-31
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-31 P190016-S012 Tula® System 30-Day Notice QJA Tympanostomy Tube Delivery Product With Drug Unknown
2026-01-21 P190016-S011 Tula Tube Delivery System (TDS) 30-Day Notice QJA Tympanostomy Tube Delivery Product With Drug Unknown
2025-10-24 P190016-S010 Tula® System 30-Day Notice QJA Tympanostomy Tube Delivery Product With Drug Unknown
2025-01-31 P190016-S009 Tula® System Normal 180 Day Track No User Fee QJA Tympanostomy Tube Delivery Product With Drug Unknown
2024-02-01 P190016-S007 Tula® System Normal 180 Day Track QJA Tympanostomy Tube Delivery Product With Drug Unknown
2023-12-22 P190016-S008 Tula System Normal 180 Day Track No User Fee QJA Tympanostomy Tube Delivery Product With Drug Unknown
2022-12-15 P190016-S006 Tula® System Real-Time Process QJA Tympanostomy Tube Delivery Product With Drug Unknown
2022-09-22 P190016-S005 Tula® System 30-Day Notice QJA Tympanostomy Tube Delivery Product With Drug Unknown
2021-09-08 P190016-S003 Tula System 30-Day Notice QJA Tympanostomy Tube Delivery Product With Drug Unknown
2020-12-30 P190016-S002 Tula System Real-Time Process QJA Tympanostomy Tube Delivery Product With Drug Unknown
2020-05-06 P190016-S001 Tula SystemTube Delivery System (TDS) 30-Day Notice QJA Tympanostomy Tube Delivery Product With Drug Unknown
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2026-04-23 K252436 Tula Tympanostomy Tube Delivery Device ETD Class II Ear, Nose, Throat
Data source: openFDA · Generated 2026-08-11 12:14 · Last ingest 2026-08-11T16:13:49.849860 · Pipeline: Chrysalis Intelligence