T-Tube Drain, Round
FDA 510(k) K760778 · Heyer Schulte Corp.
510(k) numberK760778
Submission
- Device name
- T-Tube Drain, Round
- Applicant
- Heyer Schulte Corp.
Mchenry, IL, US - Received
- October 4, 1976
- Decision date
- November 3, 1976
- 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
Other 510(k)s with product code GCY
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|---|---|---|---|
| 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 |
|---|---|---|
| K792096 | 2 FR Kelman Chamber MaintainerFMI · Traditional | 11/16/1979SE |
| K790842 | Subcutaneous Tissue ExpanderLCJ · Traditional | 08/03/1979SE |
| K780706 | Lumbar Nerve Root Shield · Traditional | 09/07/1978SE |
| K780417 | Aseptic Transfer SetGAZ · Traditional | 04/18/1978SE |
| K771224 | Radovan Subcutaneous Tissue ExpanderLCJ · Traditional | 10/11/1977SE |
| K760785 | Mishler 2 Chamb Flushing Valve,Anti-SyphJXG · Traditional | 11/01/1976SE |
| K760784 | Mishler 2 Chamb Flushing Valve,StandJXG · Traditional | 11/01/1976SE |
| K760501 | Valve, Standard Model Pudenze FlushingJXG · Traditional | 08/30/1976SE |
Questions and answers
When was T-Tube Drain, Round cleared by the FDA?
T-Tube Drain, Round (K760778) received a 510(k) decision of Substantially Equivalent on November 3, 1976, 30 days after the submission was received.
What is the product code of K760778?
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.