Surgical Kit-Acufex Mosaicplasty System
FDA 510(k) K962789 · Smith & Nephew Endoscopy, Inc.
510(k) numberK962789
Submission
- Device name
- Surgical Kit-Acufex Mosaicplasty System
- Applicant
- Smith & Nephew Endoscopy, Inc.
Mansfield, MA, US - Received
- July 17, 1996
- Decision date
- August 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
| K971268 | Bone & Marrow Cllection SystemGEY · Traditional | Biomedical International Corp. | 07/03/1997SE |
| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
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| K050580 | Smith & Nephew Intelijet Fluid Management SystemsHRX · Traditional | 04/20/2005SE |
| K992396 | Biorci ScrewHWC · Traditional | 01/12/2000SE |
| K991500 | Smith & Nephew Suture LokOCW · Traditional | 07/14/1999SE |
| K972599 | Acufex Screw CannulaHWC · Traditional | 09/19/1997SE |
Questions and answers
When was Surgical Kit-Acufex Mosaicplasty System cleared by the FDA?
Surgical Kit-Acufex Mosaicplasty System (K962789) received a 510(k) decision of Substantially Equivalent on August 14, 1996, 28 days after the submission was received.
What is the product code of K962789?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.