Atlas FDA

Titan Manufacturing Bipolar Forceps

FDA 510(k) clearance K213386 · decided 2021-10-25

Clearance details

K-number
K213386
Device name
Titan Manufacturing Bipolar Forceps
Applicant
Titan Manufacturing, Inc.
Decision
Substantially Equivalent
Date received
2021-10-13
Decision date
2021-10-25
Days to decision
12 days
Clearance type
Special
Product code
GEI
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Malvern, PA, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL LENGTH recall (Z-0373-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH recall (Z-0374-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED, OVE recall (Z-0375-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH 8- recall (Z-0376-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL L recall (Z-0377-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" ( recall (Z-0378-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM recall (Z-0379-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7" (17.8CM) , R recall (Z-0380-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190 recall (Z-0381-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller"GERALD BIPOLAR FORCEPS INSULATED, 1.0MM TIP OVERALL LENGTH 7" (180MM recall (Z-0382-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7 recall (Z-0383-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVE recall (Z-0384-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 7 recall (Z-0385-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERA recall (Z-0386-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIPS, IRRIGATING OV recall (Z-0387-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5 recall (Z-0388-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERAL recall (Z-0389-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 7" (180M recall (Z-0390-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGT recall (Z-0391-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100M recall (Z-0392-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL recall (Z-0393-2023)Carefusion 2200 Inc2022-12-03
Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F recall (Z-0394-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (12 recall (Z-0395-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LEN recall (Z-0396-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller euro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP O recall (Z-0397-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LEN recall (Z-0398-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP recall (Z-0399-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENG recall (Z-0400-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENG recall (Z-0401-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENG recall (Z-0402-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENG recall (Z-0403-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" recall (Z-0404-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2 recall (Z-0405-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/ recall (Z-0406-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2 recall (Z-0407-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT STANDARD, 8-3/ recall (Z-0408-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, STRAIGHT, FINE 0.5MM TIP OVERALL L recall (Z-0409-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.0MM TIP, STRAIGHT MEDIUM OVERALL recall (Z-0410-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL recall (Z-0411-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LE recall (Z-0412-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STR recall (Z-0413-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, recall (Z-0414-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.0MM TIP, STR recall (Z-0415-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 0. recall (Z-0416-2023)Carefusion 2200 Inc2022-12-03
CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6" (150MM), recall (Z-0417-2023)Carefusion 2200 Inc2022-12-03