Merocel Instrument Wipe
FDA 510(k) K791736 · Xomed, Inc.
510(k) numberK791736
Submission
- Device name
- Merocel Instrument Wipe
- Applicant
- Xomed, Inc.
Jacksonville, FL, US - Received
- August 31, 1979
- Decision date
- September 19, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEC – Brush, Scrub, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971473 | Ivalon Instrument Wipe, Ivalon Knife Cleaning BlockGEC · Traditional | M-Pact Worldwide Management Corp. | 07/07/1997SE |
| K960621 | Expandacell Instrument WipeGEC · Traditional | Shippert Medical Technologies Corp. | 04/01/1996SE |
| K900691 | Biodyne Instrument WipesGEC · Traditional | Bio-Dyne, Inc. | 03/08/1990SE |
| K896085 | Surgi-BrushGEC · Traditional | Sparta Surgical Corp. | 11/08/1989SE |
| K875033 | Sterile Scrubby Scrub BrushGEC · Traditional | Medsurg Industries, Inc. | 02/19/1988SESD |
| K875129 | Steri-ClensGEC · Traditional | Absorbent Cotton Co., Inc. | 02/18/1988SE |
| K872823 | Delta ScrubGEC · Traditional | Pacific Biosystems, Inc. | 01/07/1988SE |
| K874653 | Sterile Surgical Scrub BrushGEC · Traditional | Surgikos, Inc. | 12/30/1987SE |
| K874741 | Steri-Clens(Tm) Surgical Scrub SpongeGEC · Traditional | Absorbent Cotton Co., Inc. | 12/10/1987SE |
| K870258 | Bioscrub Surgical Scrub BrushGEC · Traditional | K. W. Griffen Co. | 02/24/1987SE |
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|---|---|---|
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| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Merocel Instrument Wipe cleared by the FDA?
Merocel Instrument Wipe (K791736) received a 510(k) decision of Substantially Equivalent on September 19, 1979, 19 days after the submission was received.
What is the product code of K791736?
The FDA product code is GEC – Brush, Scrub, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4800.