Cosgrove Mitral Valve Retractor
FDA 510(k) K844177 · Kapp Surgical Instrument, Inc.
510(k) numberK844177
Submission
- Device name
- Cosgrove Mitral Valve Retractor
- Applicant
- Kapp Surgical Instrument, Inc.
Cleveland, OH, US - Received
- October 25, 1984
- Decision date
- November 8, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAD – Retractor
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional | Clarus Medical Systems, Inc. | 08/18/1998SE |
| K963006 | Scion Saphenous Vein Harvesting SystemGAD · Traditional | Scion International, Inc. | 09/20/1996SE |
| K943875 | Villalta RetractorGAD · Traditional | Hct, Inc. | 11/09/1994SE |
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Questions and answers
When was Cosgrove Mitral Valve Retractor cleared by the FDA?
Cosgrove Mitral Valve Retractor (K844177) received a 510(k) decision of Substantially Equivalent on November 8, 1984, 14 days after the submission was received.
What is the product code of K844177?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.