Redyrob-Closed Wound Drainage System
FDA 510(k) K972703 · B.Braun Medical, Inc.
510(k) numberK972703
Submission
- Device name
- Redyrob-Closed Wound Drainage System
- Applicant
- B.Braun Medical, Inc.
Bethlehem, PA, US - Received
- July 18, 1997
- Decision date
- October 1, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
| K933170 | Inman Poole Tip Suction Probe W/Tubing KitGCY · Traditional | Inman Medical Corp. | 09/16/1993SE |
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Questions and answers
When was Redyrob-Closed Wound Drainage System cleared by the FDA?
Redyrob-Closed Wound Drainage System (K972703) received a 510(k) decision of Substantially Equivalent on October 1, 1997, 75 days after the submission was received.
What is the product code of K972703?
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.