Microline Cat #100
FDA 510(k) K880943 · Microline Pentax, Inc.
510(k) numberK880943
Submission
- Device name
- Microline Cat #100
- Applicant
- Microline Pentax, Inc.
Devers, MA, US - Received
- March 7, 1988
- Decision date
- May 26, 1988
- 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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| K974066 | Re-New Forceps Laparoscopic Surgical TipsGEI · Traditional | 01/22/1998SE |
| K970826 | Selecta-Tip Laparoscopic ScissorsGEI · Traditional | 03/28/1997SE |
| K962119 | Re-New Laparoscopic InstrumentsGEI · Traditional | 08/09/1996SE |
| K932648 | Quick Switch Laparoscopic InstrumentsGCJ · Traditional | 10/12/1993SE |
| K897093 | Intraocular Microscissors by Means of Gamma Radia.HNF · Traditional | 04/04/1990SE |
Questions and answers
When was Microline Cat #100 cleared by the FDA?
Microline Cat #100 (K880943) received a 510(k) decision of Substantially Equivalent on May 26, 1988, 80 days after the submission was received.
What is the product code of K880943?
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.