Weitianer Mastoid 3 VS 4 Blunt & Sharp Prongs
FDA 510(k) K852530 · The Huxley Instrument Corp.
510(k) numberK852530
Submission
- Device name
- Weitianer Mastoid 3 VS 4 Blunt & Sharp Prongs
- Applicant
- The Huxley Instrument Corp.
Penn Yan, NY, US - Received
- June 14, 1985
- Decision date
- June 28, 1985
- 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 |
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More from Hct, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K852721 | Bozeman Uterine Forceps, Straight, 10+410 0R 420HCZ · Traditional | 09/06/1985SE |
| K853016 | Stille Angular Rongeur, 8-3/4 SS 410 · Traditional | 08/07/1985SE |
| K852993 | Bone Rongeurs · Traditional | 08/07/1985SE |
| K853015 | Self-Centering Bone Holding Forceps, 10-1/4 SS420GEN · Traditional | 07/29/1985SE |
| K852716 | Taylor Percussion Hammer SS 410 or 420GWZ · Traditional | 07/26/1985SE |
| K852735 | Scalpel Handle #7 SS 410 or 420GDZ · Traditional | 07/15/1985SE |
| K852734 | O.R. Scissors, Straight, 5-1/2+SHP/SHP SS · Traditional | 07/15/1985SE |
| K852732 | Iris Scissors, Curved, 4-1/2+SS 410 or 420 · Traditional | 07/15/1985SE |
| K852731 | Lister Bandage Scissors, 5-1/2+SS 410 or 420 · Traditional | 07/15/1985SE |
| K852730 | Crile Forceps, Striaght, 6-1/4+SS 410 or 420GEN · Traditional | 07/15/1985SE |
Questions and answers
When was Weitianer Mastoid 3 VS 4 Blunt & Sharp Prongs cleared by the FDA?
Weitianer Mastoid 3 VS 4 Blunt & Sharp Prongs (K852530) received a 510(k) decision of Substantially Equivalent on June 28, 1985, 14 days after the submission was received.
What is the product code of K852530?
The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.