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Kirwan Surgical Products, LLC

FDA Regulatory Profile

Summary

Total Recalls
7 (7 Class I)
510(k) Clearances
19
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0659-2025Class INidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product November 14, 2024
Z-0658-2025Class IWalcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: TNovember 14, 2024
Z-0655-2025Class IKirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog NumbeNovember 14, 2024
Z-0657-2025Class IAmbler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable MiNovember 14, 2024
Z-0656-2025Class IAccutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog NumNovember 14, 2024
Z-0660-2025Class IOptikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: November 14, 2024
Z-0654-2025Class IKirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-November 14, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K231872Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris LiAugust 25, 2023
K100912DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SAugust 19, 2010
K070360KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601August 7, 2007
K060915KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERSApril 17, 2007
K062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIESMarch 9, 2007
K052203AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600October 20, 2005
K023482AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500January 15, 2003
K992218DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601July 30, 1999
K982176KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATORSeptember 18, 1998
K971341KIRWAN MODEL 28 1000 BIPOLAR COAGULATORMay 22, 1997
K965241BIPOLAR SUCTION COAGULATORFebruary 28, 1997
K962678BIPOLAR PENCIL COAGULATORAugust 14, 1996
K960455BIPOLAR SUCTION COAGULATORFebruary 27, 1996
K930113KIRWAN IRRIGATION/ASPIRATION HANDPIECEFebruary 17, 1994
K925621IRRIGATION/ASPIRATION TUBING SETMay 7, 1993
K913514ELECTROSURGICAL UNIT CABLENovember 5, 1991
K901896ENDOMETRIAL SAMPLERAugust 13, 1990
K901897ZEPPELIN FORCEPSJune 29, 1990
K900533DISPOSABLE BIPOLAR COAGULATING FORCEPSApril 9, 1990