Clamp Covers
FDA 510(k) K790952 · Medi-Spec
510(k) numberK790952
Submission
- Device name
- Clamp Covers
- Applicant
- Medi-Spec
Mchenry, IL, US - Received
- May 22, 1979
- Decision date
- June 5, 1979
- 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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|---|---|---|---|
| K152538 | JRP Wound SpreaderGAD · Traditional | J.R. Parker, LLC | 04/13/2016SE |
| K151104 | Otelo LLGAD · Traditional | Spineart | 01/06/2016SE |
| K132645 | Thoratrak Mics Retractor System, Rack, BladesGAD · Traditional | Medtronic, Inc. | 10/04/2013SE |
| K071775 | DashGAD · Traditional | Ezsurgical | 08/07/2007SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | Apple Medical Corp. | 04/26/2005SE |
| K043602 | Quadrant Retractor SystemGAD · Traditional | Medtronic Sofamor Danek | 02/23/2005SE |
| K001339 | MRI Fastsystem Retractor SystemGAD · Special | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 05/17/2000SE |
| 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 |
More from Hct, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833068 | Laminaria Japonica Cervical DilatorHDY · Traditional | 02/04/1984SE |
| K812694 | Whisk-RGEE · Traditional | 10/26/1981SE |
| K812426 | Uterine Aspiration Curettes(Rigid&Flex)HHK · Traditional | 10/08/1981SE |
| K801554 | Sterile Cast PaddingHIX · Traditional | 08/04/1980SE |
| K800404 | Medspec Operative Opthalmic KitHMP · Traditional | 04/24/1980SE |
| K800490 | Sterile Dressing PackKKX · Traditional | 03/12/1980SE |
| K780548 | Disposa-LoopsKKX · Traditional | 08/21/1978SE |
Questions and answers
When was Clamp Covers cleared by the FDA?
Clamp Covers (K790952) received a 510(k) decision of Substantially Equivalent on June 5, 1979, 14 days after the submission was received.
What is the product code of K790952?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.