Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic Sponges
FDA 510(k) K011191 · Medtronic Xomed, Inc.
510(k) numberK011191
Submission
- Device name
- Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic Sponges
- Applicant
- Medtronic Xomed, Inc.
Jacksonville, FL, US - Received
- April 19, 2001
- Decision date
- June 26, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K990749 | Sof-Suction Fluid Evacuation SystemHOZ · Traditional | X-Tech Medical, LLC | 04/02/1999SE |
More from X-Tech Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262235 | ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated…PGW · Traditional | 09/04/2026SE |
| K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube…ETN · Traditional | 02/10/2026SE |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeETN · Special | 10/26/2023SE |
| K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)ETN · Traditional | 08/30/2023SE |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM…ETN · Traditional | 03/21/2022SE |
| K210841 | NuVent Eustachian Tube Dilation BalloonPNZ · Traditional | 08/16/2021SE |
| K202623 | Novapak Nasal Sinus Packing and StentLYA · Traditional | 12/08/2020SE |
| K200759 | NIM Vital, Nerve Integrity MonitorGWF · Traditional | 10/28/2020SE |
| K173855 | Sharpsite AC Rigid EndsocopeEOB · Traditional | 04/20/2018SE |
| K152121 | NuVent EM Sinus Dilation SystemLRC · Traditional | 12/01/2015SE |
Questions and answers
When was Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic Sponges cleared by the FDA?
Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic Sponges (K011191) received a 510(k) decision of Substantially Equivalent on June 26, 2001, 68 days after the submission was received.
What is the product code of K011191?
The FDA product code is HOZ – Sponge, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4790.