Reusable Laparoscopic Instruments W/ Electrocautery
FDA 510(k) K930666 · Snowden-Pencer
510(k) numberK930666
Submission
- Device name
- Reusable Laparoscopic Instruments W/ Electrocautery
- Applicant
- Snowden-Pencer
Tucker, GA, US - Received
- February 9, 1993
- Decision date
- May 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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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| K924149 | Endo I/A ProbeGCJ · Traditional | 01/26/1993SE |
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| K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700HIF · Traditional | 06/04/1992SE |
| K913979 | Endo I/A Y SetHIF · Traditional | 11/27/1991SE |
| K913835 | Snowden-Pencer Insufflator Tubing SetHIF · Traditional | 11/07/1991SE |
| K861372 | Electrosurgical Cutting and Coagulation AccessoryGEI · Traditional | 06/19/1986SE |
Questions and answers
When was Reusable Laparoscopic Instruments W/ Electrocautery cleared by the FDA?
Reusable Laparoscopic Instruments W/ Electrocautery (K930666) received a 510(k) decision of Substantially Equivalent on May 19, 1994, 464 days after the submission was received.
What is the product code of K930666?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.