Solcovac Wound Drainage System
FDA 510(k) K915867 · Solco Basle, Inc.
510(k) numberK915867
Submission
- Device name
- Solcovac Wound Drainage System
- Applicant
- Solco Basle, Inc.
Hingham, MA, US - Received
- December 31, 1991
- Decision date
- August 14, 1992
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
Other 510(k)s with product code GCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972703 | Redyrob-Closed Wound Drainage SystemGCY · Traditional | B.Braun Medical, Inc. | 10/01/1997SE |
| K971036 | Odontit Autogenous Bone Collection DeviceGCY · Traditional | Interpore Intl. | 06/03/1997SE |
| 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 |
|---|---|---|
| K913247 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | 02/25/1993SE |
| K913177 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | 02/25/1993SE |
| K896858 | Solcotrans Intraoperative Autotransfusion SystemCAC · Traditional | 04/05/1990SE |
| K896857 | Solcotrans Orthopaedic Drainage/Reinfusion SystemCAC · Traditional | 04/05/1990SE |
| K896203 | Solcosept(Tm) Blood Transfusion FilterCAK · Traditional | 02/01/1990SE |
| K883058 | Solcotrans Ortho. Drainage/Reinfusion SystemCAC · Traditional | 10/28/1988SE |
| K872590 | Solcotrans Chest Drainage Autotransfusion SystemCAC · Traditional | 09/04/1987SE |
| K872157 | Hall Vein StripperDWQ · Traditional | 07/07/1987SE |
| K843821 | Solco Basle Intraoperative AutottrnsfusCAC · Traditional | 10/01/1985SE |
Questions and answers
When was Solcovac Wound Drainage System cleared by the FDA?
Solcovac Wound Drainage System (K915867) received a 510(k) decision of Unknown on August 14, 1992, 227 days after the submission was received.
What is the product code of K915867?
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.