Atlas FDA

VENTILATION TUBES

FDA 510(k) clearance K960477 · decided 1996-02-26

Clearance details

K-number
K960477
Device name
VENTILATION TUBES
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
1996-02-01
Decision date
1996-02-26
Days to decision
25 days
Clearance type
Traditional
Product code
ETD
Device class
2
Regulation number
874.3880
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Tula Tympanostomy Tube Delivery Device (K252436)Tusker Medical, Inc.2026-04-23
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) (K250256)Aventamed Dac2025-04-28
Solo+ Tympanostomy Tube Device (TTD) (K232702)Aventamed Dac2024-05-20
Biowy Tym Tube (TT) (K233658)Biowy Corporation2024-02-16
Tympanostomy Tubes (K232059)Grace Medical, Inc.2023-11-24
Hummingbird Tympanostomy Tube System (K221254)Preceptis Medical, Inc.2022-07-27
Hummingbird Tympanostomy Tube System (K200952)Preceptis Medical, Inc.2020-06-05
TULA Tube Delivery System (K171239)Tusker Medical2017-06-28
Hummingbird Tympanostomy Tube (K151830)Preceptis Medical2015-09-21
Ventilation (Tympanostomy) Tubes (K151067)Medtronic Xomed, Inc.2015-07-22
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) (K142282)Preceptis Medical2015-04-23
PRECEPTIS TYMPANOSTOMY TUBE INSERTER (K133921)Preceptis Medical2014-08-22

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10