Flexfinder Guide Wire(Regular Shaft/Stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire (Regular Shaft/Stiff Shaft) No
FDA 510(k) K990765 · Flexmedics
510(k) numberK990765
Submission
- Device name
- Flexfinder Guide Wire(Regular Shaft/Stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire (Regular Shaft/Stiff Shaft) No
- Applicant
- Flexmedics
Minnetonka, MN, US - Received
- March 8, 1999
- Decision date
- March 15, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OCY – Endoscopic Guidewire, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
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More from Coloplast A/S
| 510(k) | Device | Decision |
|---|---|---|
| K964955 | Flexfinder Guidewire (Regular Shaft/Stiff Shaft) Marked Ink Bands…OCY · Traditional | 02/14/1997SE |
| K952430 | Finesse Guidewire CoronaryDQX · Traditional | 08/18/1995SE |
| K943390 | Flexfinder GuidewireDQX · Traditional | 06/27/1995SE |
| K942074 | Flexfinder GuidewireKNY · Traditional | 06/24/1994SE |
| K934265 | Flexmedics Super-Seven Stranded Nickel-Titanium ArchwireDZC · Traditional | 01/21/1994SE |
| K912843 | Flexmedics Retract Orth Probe, Pettine Bone ProbeHXB · Traditional | 09/24/1991SE |
| K910674 | Flexmedics Malleable CannulaHRX · Traditional | 04/12/1991SE |
| K895899 | Flexmedics Guidewire .012 OnlyDQX · Traditional | 05/23/1990SE |
| K893626 | Flexmedics GuidewireDQX · Traditional | 09/26/1989SE |
| K885086 | Tin Coated Niti Orthodontic Arch WiresEJF · Traditional | 01/10/1989SE |
Questions and answers
When was Flexfinder Guide Wire(Regular Shaft/Stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire (Regular Shaft/Stiff Shaft) No cleared by the FDA?
Flexfinder Guide Wire(Regular Shaft/Stiff Shaft) Marked Ink Bands, Flexfinder Guide Wire (Regular Shaft/Stiff Shaft) No (K990765) received a 510(k) decision of Substantially Equivalent on March 15, 1999, 7 days after the submission was received.
What is the product code of K990765?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.