Ksea Unimat 45
FDA 510(k) K981703 · Karl Storz Endoscopy
510(k) numberK981703
Submission
- Device name
- Ksea Unimat 45
- Applicant
- Karl Storz Endoscopy
Culver City, CA, US - Received
- May 14, 1998
- Decision date
- August 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| 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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| K043375 | Fisch Titanium Middle Ear ProsthesesETA · Traditional | 01/24/2005SE |
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| K030009 | Ksea Powershaver System S2HRX · Traditional | 04/02/2003SE |
| K023924 | Autocon II 200 Electrosurgical GeneratorGEI · Traditional | 02/21/2003SE |
| K023187 | Ksea SpinoscopeHRX · Traditional | 12/02/2002SE |
| K011700 | Modulith SLK LithotripterLNS · Traditional | 08/16/2002SE |
| K021776 | Ksea Quadro SwitchOCX · Traditional | 08/15/2002SE |
| K013107 | Bioabsorbable Interference Screw MegafixHWC · Traditional | 02/26/2002SE |
| K011841 | Ksea Sawahle Electromechanical MorcellatorGCJ · Traditional | 09/10/2001SE |
| K010569 | Ksea Universal Laparomat Laparoscopic Suction and Irrigation PumpGCJ · Traditional | 04/09/2001SE |
Questions and answers
When was Ksea Unimat 45 cleared by the FDA?
Ksea Unimat 45 (K981703) received a 510(k) decision of Substantially Equivalent on August 12, 1998, 90 days after the submission was received.
What is the product code of K981703?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.