Frazier-Ferguson Suction Tubes (Disp.)
FDA 510(k) K801612 · Edward Weck, Inc.
510(k) numberK801612
Submission
- Device name
- Frazier-Ferguson Suction Tubes (Disp.)
- Applicant
- Edward Weck, Inc.
Mchenry, IL, US - Received
- July 15, 1980
- Decision date
- August 4, 1980
- 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 |
| 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.
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|---|---|---|
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| K911915 | Hemoclip IIFZP · Traditional | 01/09/1992SE |
| K914470 | Pneumo-Seal(Tm)GCJ · Traditional | 11/29/1991SE |
| K911272 | Endoscopic Needlholder Cat. Number 114705FHG · Traditional | 07/02/1991SE |
| K902108 | Hem-O-Lok(Tm)FZP · Traditional | 08/06/1990SE |
| K902232 | Weck Electrosurgical Generator #174200GEI · Traditional | 08/02/1990SE |
| K897045 | Bowie-Dick Test Card Catalog Number 008018JOJ · Traditional | 02/15/1990SE |
| K871110 | Coronary Artery Bypass Graft (Cabg) MarkerDSY · Traditional | 08/27/1987SE |
| K851251 | Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional | 07/02/1985SE |
Questions and answers
When was Frazier-Ferguson Suction Tubes (Disp.) cleared by the FDA?
Frazier-Ferguson Suction Tubes (Disp.) (K801612) received a 510(k) decision of Substantially Equivalent on August 4, 1980, 20 days after the submission was received.
What is the product code of K801612?
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.