Suction Reservoir
FDA 510(k) K830607 · Sil-Med Corp.
510(k) numberK830607
Submission
- Device name
- Suction Reservoir
- Applicant
- Sil-Med Corp.
Mchenry, IL, US - Received
- February 25, 1983
- Decision date
- May 2, 1983
- 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 |
|---|---|---|
| K972521 | Navigator (Stylet) 2006GAH · Traditional | 10/01/1997SE |
| K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IIFJS · Traditional | 07/18/1997SE |
| K961194 | Antimicrobial Mediastinal Silicone DrainGBW · Traditional | 08/08/1996SE |
| K961295 | Sapphire Line Flat Drain/Kit with Spi-Argent II W/Or W/Out TrocarGBX · Traditional | 06/26/1996SE |
| K960099 | Penrose Drain Models 6001 - 6007GCY · Traditional | 03/11/1996SE |
| K955463 | Grip-A-BootsLXZ · Traditional | 01/23/1996SE |
| K942709 | Mediastinal Silicone DrainsGBW · Traditional | 01/04/1996SN |
| K926496 | Sil-Slip (Coated/Regular(Non-Coated)Thoracic DrainGBX · Traditional | 05/24/1995SE |
| K926495 | Sil-Slip Round Wound Drain (Coated)/Blue StripeGBX · Traditional | 02/02/1994SE |
| K926408 | Sil-Slip Flat Suction DrainGBX · Traditional | 02/02/1994SE |
Questions and answers
When was Suction Reservoir cleared by the FDA?
Suction Reservoir (K830607) received a 510(k) decision of Substantially Equivalent on May 2, 1983, 66 days after the submission was received.
What is the product code of K830607?
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.