Op-Flex Sump Suction Set with Diffuser Tip
FDA 510(k) K935531 · Puritas Health Care, Inc.
510(k) numberK935531
Submission
- Device name
- Op-Flex Sump Suction Set with Diffuser Tip
- Applicant
- Puritas Health Care, Inc.
New Milford, CT, US - Received
- November 16, 1993
- Decision date
- May 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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| K052286 | Deutsch Anti-Blockage Wound DrainGBX · Traditional | The Catheter Exchange, Inc. | 10/21/2005SE |
| K043515 | GraftsaverGBX · Traditional | Vescare, Inc. | 03/31/2005SE |
| K013417 | Misonix Irrigation System Moedl BC20PGBX · Traditional | Misonix, Inc. | 01/10/2002SE |
| K000704 | DMC Saphenous Vein Distention System (SVDS)GBX · Traditional | Dmc Medical, Ltd. | 05/19/2000SE |
| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional | Allegiance Healthcare Corp. | 12/04/1997SE |
| K972635 | Ultracell Suction SpongeGBX · Traditional | Ultracell Medical Technologies, Inc. | 10/01/1997SE |
| K965146 | Flat Closed Wound Drain with TrocarGBX · Traditional | Axiom Medical, Inc. | 03/10/1997SE |
More from Axiom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K942339 | Skin Neuveau Scar TreatmentMDA · Traditional | 11/28/1994SE |
| K941197 | Silk*Skin Scar TreatmentMDA · Traditional | 08/11/1994SE |
| K935600 | Tracheal Suction CatheterBSY · Traditional | 05/10/1994SESK |
| K940074 | Y-Type Blood Administration SetBRZ · Traditional | 04/21/1994SE |
| K940055 | MultisetBRZ · Traditional | 04/15/1994SE |
| K940054 | Measured Volume Solution Administration SetFPA · Traditional | 04/15/1994SE |
| K935583 | Suction Set, TrachaelBSY · Traditional | 04/11/1994SESK |
| K940070 | Stopcock Intravenous TherapyFMG · Traditional | 04/04/1994SE |
| K940056 | Winged Infusion Set A-Port Vascular Access SystemFPA · Traditional | 04/04/1994SE |
| K935532 | Transfer SetLHI · Traditional | 04/04/1994SE |
Questions and answers
When was Op-Flex Sump Suction Set with Diffuser Tip cleared by the FDA?
Op-Flex Sump Suction Set with Diffuser Tip (K935531) received a 510(k) decision of Substantially Equivalent on May 5, 1994, 170 days after the submission was received.
What is the product code of K935531?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.