Chrysalis Intelligence · Sponsors · Unimax Medical Systems, Inc.

Unimax Medical Systems, Inc.

New Taipei, TW · 1 510(k) clearances · 1 recalls

Total clearances
1
2021-11-05 → 2021-11-05
Last 12 months
0
Product codes
1
Most recent
2021-11-05
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 1 2021-11-05
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2024-06-25
DateSeverityStatusRecall # ProductCodeReason
2024-06-25 Class II Ongoing Z-3164-2024 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Service… The tube may fall into the surgical site during the grasping process.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-11-05 K211577 SoftFix Balloon Trocar GCJ Class II Gastroenterology, Urology