Chrysalis Intelligence · Sponsors · Kirwan Surgical Products, LLC

Kirwan Surgical Products, LLC

Marshfield, MA, US · 1 510(k) clearances · 7 recalls (7 Class I)

Total clearances
1
2023-08-25 → 2023-08-25
Last 12 months
0
Product codes
1
Most recent
2023-08-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 1 2023-08-25
Safety

Recalls (7)

Class I (serious)
7
Risk of injury / death
Total recalls
7
Currently ongoing
7
Most recent
2024-11-14
DateSeverityStatusRecall # ProductCodeReason
2024-11-14 Class I Ongoing Z-0660-2025 Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Micro… Potential for the outer stainless-steel tube to break or detach.
2024-11-14 Class I Ongoing Z-0659-2025 Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Dis… Potential for the outer stainless-steel tube to break or detach.
2024-11-14 Class I Ongoing Z-0658-2025 Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Micros… Potential for the outer stainless-steel tube to break or detach.
2024-11-14 Class I Ongoing Z-0657-2025 Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar … Potential for the outer stainless-steel tube to break or detach.
2024-11-14 Class I Ongoing Z-0656-2025 Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The … Potential for the outer stainless-steel tube to break or detach.
2024-11-14 Class I Ongoing Z-0655-2025 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The D… Potential for the outer stainless-steel tube to break or detach.
2024-11-14 Class I Ongoing Z-0654-2025 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposab… Potential for the outer stainless-steel tube to break or detach.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2023-08-25 K231872 Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) GEI Class II General, Plastic Surgery