SoftFix Balloon Trocar
FDA 510(k) K211577 · Unimax Medical Systems, Inc.
510(k) numberK211577
Submission
- Device name
- SoftFix Balloon Trocar
- Applicant
- Unimax Medical Systems, Inc.
New Taipei, TW - Received
- May 21, 2021
- Decision date
- November 5, 2021
- 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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| K103508 | Unmiax Laparoscopic InstrumentGEI · Traditional | 12/20/2011SE |
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Questions and answers
When was SoftFix Balloon Trocar cleared by the FDA?
SoftFix Balloon Trocar (K211577) received a 510(k) decision of Substantially Equivalent on November 5, 2021, 168 days after the submission was received.
What is the product code of K211577?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.