Eye Sponge or Spear
FDA 510(k) K834356 · Jedmed Instrument Co.
510(k) numberK834356
Submission
- Device name
- Eye Sponge or Spear
- Applicant
- Jedmed Instrument Co.
Mchenry, IL, US - Received
- December 13, 1983
- Decision date
- March 16, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOZ – Sponge, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4790
- Specialty
- Ophthalmic
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132796 | Suntouch Eye SpearHOZ · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 10/30/2013SE |
| K130117 | Network Eye Spears, Points, Drains, Wicks and ShieldsHOZ · Traditional | Network Medical Products, Ltd. | 10/29/2013SE |
| K091240 | Alphamed Surgical Spear, Model 70-5000HOZ · Traditional | Alphamed, Inc. | 10/23/2009SE |
| K082460 | Cenefom Pva Surgical SpearHOZ · Traditional | Longtek Scientific Co., Ltd. | 12/15/2008SE |
| K012196 | Ultracell Absorbent StickHOZ · Traditional | Ultracell Medical Technologies, Inc. | 08/24/2001SE |
| K011191 | Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic SpongesHOZ · Traditional | Medtronic Xomed, Inc. | 06/26/2001SE |
| K003842 | Prescott's Surgical SpearHOZ · Traditional | Prescott'S, Inc. | 04/13/2001SE |
| K002279 | ML Eye Spear, Model ML 27 EsHOZ · Traditional | Med-Logics, Inc. | 08/18/2000SE |
| K993883 | M-Pact Corneal Light ShieldHOZ · Traditional | M-Pact Corp. | 12/21/1999SE |
| K990671 | Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument WipeHOZ · Traditional | Hurricane Medical | 05/10/1999SE |
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| K021750 | Lid Chain Eyelid WeightsMML · Traditional | 01/27/2003SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | 11/13/1995SE |
| K944032 | Video Scope System (Laryngoscope)ENZ · Traditional | 09/15/1995SE |
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | 08/11/1995SE |
| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
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Questions and answers
When was Eye Sponge or Spear cleared by the FDA?
Eye Sponge or Spear (K834356) received a 510(k) decision of Substantially Equivalent on March 16, 1984, 94 days after the submission was received.
What is the product code of K834356?
The FDA product code is HOZ – Sponge, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4790.