Hydrofera Surgical Spear
FDA 510(k) K974313 · Hydrofera, LLC
510(k) numberK974313
Submission
- Device name
- Hydrofera Surgical Spear
- Applicant
- Hydrofera, LLC
Willimantic, CT, US - Received
- November 17, 1997
- Decision date
- March 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HOZ – Sponge, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4790
- Specialty
- Ophthalmic
Other 510(k)s with product code HOZ
| 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 |
More from Hurricane Medical
| 510(k) | Device | Decision |
|---|---|---|
| K190268 | Hydrofera Blue READY - BorderFRO · Traditional | 11/06/2019SE |
| K130670 | Hydrofera Blue Pu Bacteriostatic DressingFRO · Traditional | 01/02/2014SE |
| K023138 | Hydrofera Bacteriostatic Wound DressingFRO · Traditional | 01/17/2003SE |
| K013462 | Hydrofera Bacteriostatic Wound DressingFRO · Traditional | 01/11/2002SE |
| K983276 | Hydrofera Bacteristatic Nasal DressingEMX · Traditional | 09/14/1999SE |
| K974316 | Hydrofera Femoral WickEFQ · Traditional | 02/13/1998SE |
Questions and answers
When was Hydrofera Surgical Spear cleared by the FDA?
Hydrofera Surgical Spear (K974313) received a 510(k) decision of Substantially Equivalent on March 2, 1998, 105 days after the submission was received.
What is the product code of K974313?
The FDA product code is HOZ – Sponge, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4790.