Amer. Surgical Corp. Extra Plus Pak
FDA 510(k) K841738 · American Surgical Co., Inc.
510(k) numberK841738
Submission
- Device name
- Amer. Surgical Corp. Extra Plus Pak
- Applicant
- American Surgical Co., Inc.
Mchenry, IL, US - Received
- April 27, 1984
- Decision date
- October 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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More from Visioncare Devices, Inc.
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|---|---|---|
| K112598 | American Surgical Company/ Neurosurgical Sponges (Brand)HBA · Special | 06/20/2013SE |
| K121822 | DelicotHBA · Special | 09/10/2012SE |
| K834162 | Vit PacHQE · Traditional | 02/07/1986SE |
| K834160 | Vitreonic PlusHQE · Traditional | 02/07/1986SE |
| K834163 | UltravitHQE · Traditional | 12/28/1983SE |
| K834161 | Universal PacHQC · Traditional | 12/28/1983SE |
| K834159 | Phacotron PlusHQC · Traditional | 12/28/1983SE |
| K834158 | Extra Sensory PlusHQC · Traditional | 12/28/1983SE |
| K833697 | Extra Sensory Pak-Dispos. AccessHQC · Traditional | 12/28/1983SE |
| K833617 | Extra Plus TMHQC · Traditional | 12/28/1983SE |
Questions and answers
When was Amer. Surgical Corp. Extra Plus Pak cleared by the FDA?
Amer. Surgical Corp. Extra Plus Pak (K841738) received a 510(k) decision of Substantially Equivalent on October 5, 1984, 161 days after the submission was received.
What is the product code of K841738?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.