Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000
FDA 510(k) K950495 · Surgical Dynamics, Inc.
510(k) numberK950495
Submission
- Device name
- Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000
- Applicant
- Surgical Dynamics, Inc.
Concord, CA, US - Received
- February 6, 1995
- Decision date
- May 9, 1995
- 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
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 |
More from Shenzhen Kingboom Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K960046 | Surgical Dynamics 30K Working Channel ScopeHRX · Traditional | 04/02/1996SE |
| K942987 | Nucleotome L KitGET · Traditional | 10/30/1995SE |
| K954193 | Surgical Dynamics 30K Working Channel Scope & Instrument SetHRX · Traditional | 10/23/1995SE |
| K931109 | Nucleotome E KitHRX · Traditional | 03/29/1994SN |
| K921950 | Surgical Dynamics Discography SystemFMI · Traditional | 06/07/1993SEKD |
| K923525 | Nucleotome 3.5 MM Automated Percutaneous LumbarHRX · Traditional | 02/09/1993SE |
| K914282 | Nucleotome(R) II (VERSION2) Tissue Aspira/CutterHRX · Traditional | 12/19/1991SE |
| K913145 | Nucleotome Tissue Aspirator/CutterHRX · Traditional | 12/19/1991SE |
| K902778 | Surgical Dynamics Nucleotome II Tissue Aspir/CuterHRX · Traditional | 10/30/1990SE |
| K894336 | Surgical Dynamics Discography System · Traditional | 08/04/1989SEKD |
Questions and answers
When was Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000 cleared by the FDA?
Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000 (K950495) received a 510(k) decision of Substantially Equivalent on May 9, 1995, 92 days after the submission was received.
What is the product code of K950495?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.