Storz Aspiration Machine Sam 5000
FDA 510(k) K843644 · Storz Instrument Co.
510(k) numberK843644
Submission
- Device name
- Storz Aspiration Machine Sam 5000
- Applicant
- Storz Instrument Co.
St. Louis, MO, US - Received
- September 17, 1984
- Decision date
- November 16, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code BTA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/26/2026SE |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/15/2026SE |
| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 05/12/2026SE |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional | Shenzhen Dongjiang Technology Co., Ltd. | 04/14/2026SE |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 03/13/2026SE |
| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special | Shenzhen Desida Technology Co., Ltd. | 06/06/2025SE |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
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| K972664 | Storz Millennium Viscous Fluid SystemMRH · Traditional | 10/10/1997SE |
| K971439 | Storz Microflow and Storz Standard Phacoemulsification NeedlesHQC · Traditional | 06/17/1997SE |
| K964743 | Storz E8010 Ergotec/Premiere AdaptorHQE · Traditional | 02/03/1997SE |
| K960024 | Storz D7120 Phaco Handpiece Maintenance Kit & Storz D7125 Phaco Handpiece Needle WrenchHQC · Traditional | 09/20/1996SE |
| K960061 | Storz D7108 Microscissors Handpiece/Storz D7106 Microscissors Drive TubeHQE · Traditional | 09/18/1996SE |
| K960003 | Storz D7116 Microvit Vitrectomy Cutter ExtensionHQC · Traditional | 08/29/1996SE |
| K962131 | Storz D4600 Air Exchange Line PackHQC · Traditional | 08/23/1996SE |
| K961874 | Storz DP5100 Anterior Collection Cassette PackHQC · Traditional | 08/06/1996SE |
Questions and answers
When was Storz Aspiration Machine Sam 5000 cleared by the FDA?
Storz Aspiration Machine Sam 5000 (K843644) received a 510(k) decision of Substantially Equivalent on November 16, 1984, 60 days after the submission was received.
What is the product code of K843644?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.