Opthalmic Wipe
FDA 510(k) K942897 · Surgin Surgical Instrumentation, Inc.
510(k) numberK942897
Submission
- Device name
- Opthalmic Wipe
- Applicant
- Surgin Surgical Instrumentation, Inc.
Tustin, CA, US - Received
- June 20, 1994
- Decision date
- August 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQZ – Frame, Spectacle
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5842
- Specialty
- Ophthalmic
Other 510(k)s with product code HQZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952597 | View Point, Dorion, Ruddy Project, Ultra Flex, Trillon, Bay Boy, Shield Ski, Sun…HQZ · Traditional | Point of View Optical Outlet, Inc. | 09/12/1995SE |
| K944313 | Spectacle FrameHQZ · Traditional | Sun Hing Optical Manufactory , Ltd. | 03/28/1995SE |
| K945770 | Optical FramesHQZ · Traditional | Ramada Optics, Inc. | 12/15/1994SE |
| K945392 | Spectacle FrameHQZ · Traditional | Seo Han Corp., Ltd. | 12/15/1994SE |
| K945176 | Spectacle Frame or Eyeglass FramesHQZ · Traditional | Optipia Trading Co. | 12/15/1994SE |
| K945350 | Frame, SpectaclesHQZ · Traditional | Taiwan Eva Industrial Co., Inc. | 12/13/1994SE |
| K945342 | MAG-1 Spectacle FrameHQZ · Traditional | Criss Optical Mfg. Co., Inc. | 11/28/1994SE |
| K945450 | Frame, SpectacleHQZ · Traditional | Kookje Apis Industrial Co. | 11/22/1994SE |
| K945340 | Spectacle Frames or Eyeglass FramesHQZ · Traditional | Mi Mun Corp. | 11/22/1994SE |
| K945323 | Spectacle FrameHQZ · Traditional | M.Y. Vision Corp. | 11/22/1994SE |
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| K980849 | Surgin KitMSR · Traditional | 07/09/1998SE |
| K954238 | Surgin Genisis HandpieceHQC · Traditional | 12/08/1995SE |
| K950600 | Vacuum Surge SupresserHQC · Traditional | 05/10/1995SE |
| K942945 | Cassette System for StorzHQC · Traditional | 12/05/1994SE |
| K942944 | Irrigation/Bipolar SetGEI · Traditional | 09/27/1994SE |
Questions and answers
When was Opthalmic Wipe cleared by the FDA?
Opthalmic Wipe (K942897) received a 510(k) decision of Substantially Equivalent on August 5, 1994, 46 days after the submission was received.
What is the product code of K942897?
The FDA product code is HQZ – Frame, Spectacle, a Class I (low risk) device regulated under 21 CFR 886.5842.