Sarns Mini-Sucker
FDA 510(k) K810416 · 3M Health Care, Sarns
510(k) numberK810416
Submission
- Device name
- Sarns Mini-Sucker
- Applicant
- 3M Health Care, Sarns
Mchenry, IL, US - Received
- February 18, 1981
- Decision date
- March 5, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4680
- Specialty
- General, Plastic Surgery
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| K972703 | Redyrob-Closed Wound Drainage SystemGCY · Traditional | B.Braun Medical, Inc. | 10/01/1997SE |
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| K963839 | Cordis Suction Reservoir - Model Number: 910-500GCY · Traditional | Cordis Corp. | 12/12/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | Sil-Med Corp. | 03/11/1996SE |
| K950754 | Macro Suction Tube Model No 10061GCY · Traditional | Dlp, Inc. | 04/25/1995SE |
| K936223 | Pressure Irrigating SystemGCY · Traditional | Level 1 Technologies, Inc. | 05/12/1994SE |
| K930615 | Autovac Closed Wound Suction SystemGCY · Traditional | Boehringer Laboratories | 02/22/1994SE |
| K933319 | Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional | Birtcher Medical Systems, Inc. | 10/27/1993SE |
| K933306 | Imc 5.0MM Irrigation/Aspiration Probe W/HolesGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
| K933305 | Imc 5.0MM Irrigation/Aspiration ProbeGCY · Traditional | Inman Medical Corp. | 10/05/1993SE |
More from Inman Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K960916 | Sams 8000 Cardioplegia MonitorDSJ · Traditional | 06/04/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 04/19/1996SE |
| K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemDWA · Traditional | 11/17/1995SE |
| K941653 | Sarns Turbo Membrane Oxygenator ModificationDTZ · Traditional | 08/24/1994SE |
| K941654 | Sarns Filtered Venous Reservior ModificationDTP · Traditional | 07/26/1994SE |
| K940651 | Sarns Ultrasonic Air SensorKRL · Traditional | 05/24/1994SE |
| K935391 | Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional | 02/24/1994SE |
| K934127 | Sarns Low Jetting Aortic Arch CannulaDWF · Traditional | 02/22/1994SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 02/04/1994SE |
| K915547 | Sarns 8000 Delphin II Centri Pump Mod W/Integr BatKFM · Traditional | 09/09/1993SE |
Questions and answers
When was Sarns Mini-Sucker cleared by the FDA?
Sarns Mini-Sucker (K810416) received a 510(k) decision of Substantially Equivalent on March 5, 1981, 15 days after the submission was received.
What is the product code of K810416?
The FDA product code is GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a Class I (low risk) device regulated under 21 CFR 878.4680.