Smith & Nephew Mis Instruments
FDA 510(k) K970949 · Smith & Nephew Endoscopy, Inc.
510(k) numberK970949
Submission
- Device name
- Smith & Nephew Mis Instruments
- Applicant
- Smith & Nephew Endoscopy, Inc.
Mansfield, MA, US - Received
- March 14, 1997
- Decision date
- April 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K093428 | Smith & Nephew Knotless Instability AnchorMBI · Traditional | 12/17/2009SE |
| K083635 | Smith & Nephew Biosure PK Interference ScrewMBI · Traditional | 01/30/2009SE |
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| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair DeviceHTN · Traditional | 10/21/2008SE |
| 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 Smith & Nephew Mis Instruments cleared by the FDA?
Smith & Nephew Mis Instruments (K970949) received a 510(k) decision of Substantially Equivalent on April 23, 1997, 40 days after the submission was received.
What is the product code of K970949?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.