Tonsil Tip Sucker 201301-000
Tonsil Tip Sucker 201301-000 is a general-purpose surgical suction system (FDA Class II; FDA product code DTS, Sucker, Cardiotomy Return, Cardiopulmonary Bypass) made by Novosci Corp., cleared under FDA 510(k) K801400 on 30 Jun 1980 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI B0662013010000), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB0662013010000 | Date26 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK801400 | Date30 Jun 1980 | StatusActive |
Official records
- FDA 510(k) database K801400
Across registries
- FDA 510(k) K801400 decided 30 Jun 1980 Active
- FDA GUDID UDI-DI B0662013010000 listed 26 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K801400
- Listed FDA GUDID B0662013010000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Tonsil Tip Sucker
- Generic name
- General-purpose surgical suction system, vacuum
- Model / Ref / Catalog
- 201301-000
- Primary DI / UDI-DI
- B0662013010000
- 510(k) Number
- FDA product code
- DTS
- GMDN term
- General-purpose surgical suction system, vacuum
- Device class
- Class II
- Regulation number
- 870.4420
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DTS (Sucker, Cardiotomy Return, Cardiopulmonary Bypass).
- FLEXIBLE INTRACARDIAC SUCTION DEVICE by Gish Biomedical, Inc.
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- Suction tip SU-20802 by SORIN GROUP ITALIA SRL
- Suction tip SU-20602 by SORIN GROUP ITALIA SRL
- Ohio Disposable Clear Suction Instrument by Airco/Ohio Medical Products
- ROBICSEK INTRACARDIAC SUCTION WAND by Gish Biomedical, Inc.
- CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS by California Medical Laboratories, Inc.
- DISPOSSABLE SUCTION TUBE, 6 FRENCH by Dlp, Inc.
- ESTECH CLEARVIEW MV ATRIAL DEPRESSOR by Estech, Inc.