360 Gas Assisted Endoscopic Applicator
FDA 510(k) K122526 · Micromedics, Inc.
510(k) numberK122526
Submission
- Device name
- 360 Gas Assisted Endoscopic Applicator
- Applicant
- Micromedics, Inc.
St. Paul, MN, US - Received
- August 20, 2012
- Decision date
- November 16, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K241739 | Endoscopic Applicator, 41 cmGCJ · Special | 07/15/2024SE |
| K123847 | Malleable Tip Endoscopic ApplicatorGCJ · Special | 01/08/2013SE |
| K120608 | Endoscopic ApplicatorGCJ · Traditional | 03/15/2012SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | 03/15/2011SE |
| K100754 | Graft Delivery System Model SA-6115FMF · Traditional | 06/09/2010SE |
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000MJV · Traditional | 03/14/2008SE |
| K061092 | Baxter Duplospray Mis ApplicatorFMF · Traditional | 09/13/2006SE |
| K051157 | Instru-Safe Instrument Protection SystemsKCT · Traditional | 09/01/2005SE |
| K050340 | Micromedics Sphenoid Sinus StentKAM · Traditional | 04/27/2005SE |
| K042834 | Micromedics Fibrijet Air Assisted Endoscopic ApplicatorGCJ · Traditional | 02/11/2005SE |
Questions and answers
When was 360 Gas Assisted Endoscopic Applicator cleared by the FDA?
360 Gas Assisted Endoscopic Applicator (K122526) received a 510(k) decision of Substantially Equivalent on November 16, 2012, 88 days after the submission was received.
What is the product code of K122526?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.